Calorie DeficiencyNCT05545943
Effects of Calorie Restriction and Cold Stimuli on Health-related Indicators, Cognitive and Motor Functions
A study testing 2-days of zero calorie restriction and whole-body cold-water immersion, 6-days of calorie restriction and 2-days of zero calorie restriction without whole-body cold-water immersion in people with Calorie Deficiency and Fasting, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Calorie Deficiency, Fasting, Cold Exposure
- What is being tested?
- 2-days of zero calorie restriction and whole-body cold-water immersion, 6-days of calorie restriction and 2-days of zero calorie restriction without whole-body cold-water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLithuania
- Study dates
- 8 Feb 2021to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index 19.5-29.9 kg/m2,
- age 18-40 years,
- no excessive regular moderate or vigorous physical activity, i.e., ≥3 times per week,
- non-smokers,
- no medications that could affect the results of experiment,
- no history of any eating, oncological, metabolic, cardiovascular, skeletal, neuromuscular, pulmonary disorders or diseases, mental disabilities or conditions that could be worsened by exposure to acute cold (14°) water or fasting and affect experimental variables,
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- no history of alcoholism or dependence on psychotropic drugs,
- no blood/needle phobia,
- no involvement in any temperature-manipulation program or extreme temperature exposure for ⩾3 months,
- Exclusion criteria: smoking, were in a weight-reduction program, followed a low-carbohydrate diet.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 2-day and 6-day Calorie Restriction and Whole-body Cooling Strategies on Health-related Indicators, Cognitive and Motor Functions
The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders.
The main questions it aims to answer were:
Read more
- Does fasting duration have any effect on fasting evoked responses?
- Does cold interventions can modulate fasting evoked responses?
- Does sex have any effect on acute fasting evoked responses?
For the first part, participants were randomly classified into 4 groups: two experimental groups: 2-days of CR (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. For the second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. Changes in anthropometric characteristics, perceived stress, metabolism, overall health (total blood count, sex hormones, etc.), psycho-emotional state, cognitive and motor functions were examined.
Read the detailed description
The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders.
At first study part, participants were randomly classified into 4 groups: two experimental groups: 2-days of calorie restriction (CR) (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. In the experimental groups, the participants were instructed to follow a prescribed zero-calorie diet with water provided ad libitum over a period of 2 or 6 days. In the control groups, the participants were instructed to maintain their previous eating habits for 2 or 6 days. Body weight and composition, heart rate variability, pulmonary gas exchange, blood pressure, and body temperature were assessed. Subsequently, participants completed self-assessment questionnaires, and then saliva samples were collected for further cortisol and sex hormones analysis, also capillary and venous blood samples were taken for ketone, glucose, insulin, lipid profile, catecholamines, brain-derived neurotrophic factor, total antioxidant capacity, malondialdehyde, glucagon, interleukin-10, metabolites of the kynurenines pathway and complete blood count concentrations evaluation. Then, the manual dexterity, and the cognitive and neuromuscular functions were assessed. The same measurements were repeated before each trial, after each trial and after 1 week.
At second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. The same measurements described in first part were repeated before each and after each condition.
- Conditions
- Calorie Deficiency, Fasting, Cold Exposure
- Being tested
- 2-days of zero calorie restriction and whole-body cold-water immersion, 6-days of calorie restriction, 2-days of zero calorie restriction without whole-body cold-water immersion, 2-days of usual diet with whole-body cold-water immersion
- Keywords
- cognition, motor function, metabolism, young adults, fasting, starvation, men, women, calorie deprivation, stress, kynurines, catecholamines, glucose tolerance, energy expenditure, weight loss
- Medical subject headings
- Fasting, Starvation, Multiple Endocrine Neoplasia Type 1, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-days of zero calorie restriction and whole-body cold-water immersionOther
The 2-days (48 hours) of zero-calorie restricted diet (with water provided ad libitum) with two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min.
6-days of calorie restrictionOther
The 6-days (144 hours) of prescribed zero-calorie prescribed diet with water provided ad libitum.
2-days of zero calorie restriction without whole-body cold-water immersionOther
2 days (48 hours) of prescribed zero-calorie diet with water provided ad libitum .
2-days of usual diet with whole-body cold-water immersionOther
Two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min. During intervention, participants were instructed to maintain their previous eating habits.
| Study group | Role | What they receive |
|---|---|---|
| 2-days of calorie restriction with whole body cooling | Experimental | Healthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) with two 10-min whole body cooling practices on separate days.
All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data. Receives: Other: 2-days of zero calorie restriction and whole-body cold-water immersion |
| 6-days of calorie restriction | Experimental | Healthy young subjects participated in 6-day CR (0 kcal with water provided ad libitum).
All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data. Receives: Other: 6-days of calorie restriction |
| 2-days of the usual diet (control) | No intervention | During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 2 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data. |
| 6 days of the usual diet (control) | No intervention | During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data. |
| 2-days of calorie restriction without whole-body cooling | Experimental | Healthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) without whole body cooling.
All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data. Receives: Other: 2-days of zero calorie restriction without whole-body cold-water immersion |
| 2-days of usual diet with whole-body cooling | Active comparator | Healthy young subjects participated two 10-min whole body cooling practices on separate days and were instructed to maintain their previous eating habits for 6 days.
All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data. Receives: Other: 2-days of usual diet with whole-body cold-water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass and body composition (kg)
Body mass and composition (in kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in body mass index (kg/m2)
The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in substrate oxidation
Oxygen consumption and carbon dioxide output every 5 s on a breath-by breath basis using an Oxycon Mobile spirometry system (Oxygen Mobile, Jaeger/ VIASYS Healthcare, Germany) was measured at rest, and the respiratory quotient (RQ=VCO2/VO2) was computed to determine substrate utilisation. The RQ values for fat was assumed as 0.7, for protein was assumed as 0.8 and for carbohydrate was assumed as 1.0.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in energy expenditure (kcal/day)
Resting energy expenditure (REE) using Weir equation modified Weir equation: REE (kcal/day)=[3.941(oxygen consumption) + 1.106(carbon dioxide output)] x 1440
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in body temperature (°C)
Rectal temperature (°C) was measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (°C) was measured with thermistors (Skin/Surface Probe, DM852, Ellab) at three sites: back, thigh, and forearm, and right lateral gastrocnemius muscle temperature (°C) was measured using a needle microprobe (MKA; Ellab).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate variability (ms)
R-R intervals (in ms) in supine resting conditions were recorded using a Polar HR sensor (Finland) and and simultaneously transferred to Polar Pro Trainer 5 software (Finland).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate variability (time domain) (ms)
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the time domain that reflects general heart rate variability (HRV), the standard deviation of normal-to-normal intervals (SDNN; estimate of overall HRV) and the root mean square of successive differences (RMSSD; estimate of short-term components of HRV) were assessed (in ms).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate variability (time domain) (Ln)
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the time domain that reflects general heart rate variability (HRV), the standard deviation of normal-to-normal intervals (SDNN; estimate of overall HRV) and the root mean square of successive differences (RMSSD; estimate of short-term components of HRV) were assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate variability (frequency domain) (ms2)
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in absolute units (in ms2).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate variability (frequency domain) (Ln)
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers were assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate variability (frequency domain) (nu)
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in normalized units (in nu).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in heart rate (bpm)
Heart rate (in bpm) was recorded using a heart rate sensor with a chest strap (Polar, Finland) in laying position at rest.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in blood pressure (mmHg)
Resting systolic and diastolic blood pressure (in mmHg) was measured using a digital electronic blood pressure monitor (Microlife, Switzerland)
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in perceived stress
Perceived stress was evaluated with visual analog scales (VAS) ranging from 0 ("no stress") to 100 ("the highest stress imaginable").according to how participants feel "right now".
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in appetite sensations
Appetite sensations (hunger and fullness) were evaluated with VAS ranging from 0 ("I am not hungry at all/not at all full") to 100 ("I have never been more hungry/totally full") according to how participants feel "right now".
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in mood state
Mood state was evaluated with Brunel mood scale according to how participants feel "right now". The scale consists of 24 items divided into six subscales: anger, confusion, depression, fatigue, tension, and vigor. The items are answered on a 5-point scale, and each subscale, with four relevant items, are summed to produce a raw score in the range of 0-16, where a higher score indicates greater endorsement of the specific mood state.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in venous complete blood count (10^9/L)
Venous complete blood count with 5 different white blood count (WBC) components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10^9/L) was performed using an automated Mythic 60 hematology analyzer (Switzerland).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in venous complete blood count (%)
Venous complete blood count with 5 different white blood count (WBC) components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in %) was performed using an automated Mythic 60 hematology analyzer (Switzerland).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in serum female sex hormones concentration (pg/mL)
The venous serum 17beta-estradiol and progesterone (in pg/mL) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in serum female sex hormones concentration (mIU/ml)
The venous serum follicle stimulating and luteinizing hormones (in mIU/ml) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in serum brain-derived neurotrophic factor concentration (pg/ml)
The venous serum brain-derived neurotrophic factor (in pg/ml) was measured using enzyme-linked immunosorbent assay kits (Cat.No. DBD00; R\&D Systems, Emeryville, USA) and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in serum interleukin-10 concentration (pg/ml)
The venous serum interleukin (in pg/ml) was measured using enzyme-linked immunosorbent assay kits (Cat. No. 30147233; IBL International GmBH, Germany) and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in serum insulin concentration (μIU/ml)
The venous serum insulin concentrations (in μIU/ml) were measured using enzyme-linked immunosorbent assay kits (Cat. No. E-EL-H2237, Elabscience, China) and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in serum glucagon concentration (pg/ml)
The venous serum glucagon concentrations (in pg/ml) were measured using enzyme-linked immunosorbent assay kits (DIAsource ImmunoAssays S.A.,Belgium) and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in plasma catecholamines concentration (ng/ml)
The venous plasma adrenaline and noradrenaline concentrations (in ng/ml) were measured using enzyme-linked immunosorbent assay kits (Cat. No. RE59242, IBL International GmbH, Germany) and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in plasma malondialdehyde concentration (nmol/ml)
The venous plasma malondialdehyde concentrations (in nmol/l) were measured using a solid phase nzyme-linked immunosorbent assay (Cat. No. E1371Hu, Bioassay Technology Laboratory, Shangai, China) and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery
Change in plasma total antioxidant capacity (mmol/l)
The venous plasma total antioxidant capacitys (in mmol/l) were measured colorimetrically with an assay kit (Cat. No.E-BC-K271-M, Elabscience Biotechnology Inc, Houston, USA) and using a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery
Change in venous glucose concentration (mmol/l)
The venous glucose concentration (in mmol/l) was measured in venous blood samples using a Glucocard X-mini plus glucose analyser (Arkray, Japan).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in insulin sensitivity
An oral glucose insulin sensitivity [OGIS] index derived from an oral glucose tolerance test was calculated.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in plasma metabolites of the kynurenine pathway (μm)
An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) to measure venous plasma levels of tryptophan, kynurenine, kynurenic acid, 3-hydroxy-kynurenine, quinolinic acid, nicotinamide and picolinic acid (in μm). The UPLC-MS/MS system used a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system was operated in electrospray positive multiple reaction monitoring mode.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in salivary cortisol concentration (µg/dl)
The saliva samples were collected to measure cortisol level (in µg/dl) using a enzyme-linked immunosorbent assay (ELISA) kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in salivary testosterone concentration (µg/dl)
The saliva samples were collected to measure testosterone level (in µg/dl) using a enzyme-linked immunosorbent assay (ELISA) kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in capillary lipid profile (mmol/l)
The capillary blood samples were collected from finger to measure lipid profile (in mmol/l) (total cholesterol, high density and low density cholesterol, triglycerides) using a CardioChek PA analyzer (USA).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in manual dexterity performance (sec)
The Grooved Pegboard was used to evaluate the ability to coordinate the fingers and manipulate objects promptly in time twice (in sec).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in information processing (μV)
Using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany), event-related potentials (ERPs) during oddball tasks by two modalities (auditory and visual) were recorded. Peak amplitudes (μV) of the N1, N2 and P3 at three sites (Fz, Cz, and Pz) were defined.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in information processing (ms)
Using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany), event-related potentials (ERPs) during oddball tasks by two modalities (auditory and visual) were recorded. Latencies (ms) of the N1, N2 and P3 at three sites (Fz, Cz, and Pz) were defined.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in brain neural network activity (µV2)
Resting electroencephalography was recorded using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany). Participant's data were averaged across the epochs for Fz, Cz and Pz electrodes, and mean absolute power (in µV2) was computed for theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz) frequency band.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in cognitive performance (ms)
Two oddball tasks were used in this study: in one task, visual stimuli were presented, and in the other task, auditory stimuli were presented. Reaction times (in ms) were measured.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in cognitive performance (%)
Two oddball tasks were used in this study: in one task, visual stimuli were presented, and in the other task, auditory stimuli were presented. Accuracy of response to the target stimulus (in %) were measured.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in reflexes (mV)
Soleus H-reflexes, V-waves and M-waves were evoked by 0.5 ms square-wave pulses using a high-voltage stimulator (Digitimer, UK). The amplitudes (in mV) of the electrical evoked reflexes were evaluated.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in reflexes (ms)
Soleus H-reflexes, V-waves and M-waves were evoked by 0.5 ms square-wave pulses using a high-voltage stimulator (Digitimer, UK). The latencies (in ms) of the electrical evoked reflexes were evaluated.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in muscle activity (mV)
Tibial muscles electromyographic (EMG) amplitude (in mV) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in muscle activity (Hz)
Tibial muscles electromyographic (EMG) frequency (in Hz) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in voluntary torque (Nm)
Isometric and isokinetic voluntary torques (in Nm) of the ankle plantar flexion/dorsiflexion muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in involuntary torque (Nm)
Involuntary torque of the ankle plantar flexion muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA) and a high-voltage stimulator (Digitimer DS7A, Digitimer, UK). Peak torques (in Nm) induced by electrical stimulation at 20 Hz,at 100 Hz, and at TT100 were measured.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in muscle contraction and relaxation (ms)
The contraction and half-relaxation time (in ms) were measured in resting TT100 contractions.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in central activation ratio (%)
To evaluate central activation ratio (CAR), a TT-100 Hz stimuli was superimposed on the maximal voluntary contraction (MVC), and the CAR was computed using the following equation: CAR = MVC/(MVC+TT-100 Hz) × 100%, where where a CAR of 100% indicates complete activation of the exercising muscle and a CAR < 100% indicates central activation failure or inhibition.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in reactive strength
The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate reactive-strength. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Reactive strength index as jump height / time to take off was calculated.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in jump performance (cm)
The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate jump performance. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Jump height (in cm) height was evaluated.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in jump performance (m/s)
The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate jump performance. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Time to take off (in m/s) was evaluated.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Secondary outcomes (8)
Change in height (m)
Height (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK)
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in skinfold thickness (mm)
Skinfolds thickness (in mm) was measured using a skinfold caliper (Saehan, Korea) at 7 sites: chest, midaxilla, triceps, subscapular, abdominal, suprailiac and thigh.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in body fatness (%)
7-Site Skinfold Jackson \& Pollock protocol was used to estimate body fat (in %) based on measurements of subcutaneous fat. As presented earlier, skinfolds were measured at 7 sites, and further body fatness was calculated as 495/(1.112-(0.00043499*s(sum of 7 skinfolds)+(0.00000055*s*s)-(0.00028826*a(age)))-450 for males and 495/(1.097-(0.00046971*s)+(0.00000056*s*s)-(0.00012828*a))-450 for females.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in physical activity (Step count)
Garmin activity tracker estimated the step count.
Measured: 3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)
Change in sleep (h)
Sleep statistics including total hours of sleep and the time spent in different sleep stages were assessed with Garmin activity tracker.
Measured: 3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)]
Change in oxygen consumption and carbon dioxide output (ml/min)
Oxygen consumption and carbon dioxide output (in ml/min) every 5 s on a breath-by breath basis using an Oxycon Mobile spirometry system (Oxygen Mobile, Jaeger/ VIASYS Healthcare, Germany) was measured at rest.
Measured: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in capillary blood ketone concentrations (mmol/l)
The capillary blood ketone concentration (in mmol/l) was assessed using an Abbott FreeStyle Optium Neo H blood glucose and ketone monitoring system (Australia) using blood obtained from a finger-prick sample.
Measured: Pre-condition, 24, 48 or 144 hours post-condition, and 1 week after recovery
Change in capillary blood glucose concentrations (mmol/L)
The capillary blood glucose concentration (in mmol/L) was assessed using an Abbott FreeStyle Optium Neo H blood glucose and ketone monitoring system (Australia) using blood obtained from a finger-prick sample.
Measured: Pre-condition, 24, 48 or 144 hours post-condition, and 1 week after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start8 Feb 2021
- Primary completion5 Sep 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Calorie DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project consisted of two parts. For the first part was used randomized parallel model, and we aimed to investigate fasting duration effect, whereas for the second part was used randomized crossover model and we aimed to investigate if cold exposure can modify fasting evoked effects on health-related indicators, cognition and motor function.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katerina Židonienė, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545943
- Sponsor's protocol ID
- LithuanianSportsU-10
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solianik R, Eimantas N, Dauge G, Brazaitis M. The effect of 6-day fasting on physical performance and neuromuscular control in healthy men. Sci Rep. 2026 Jun 20. doi: 10.1038/s41598-026-57312-9. Online ahead of print.
PubMed 42323358Solianik R, Eimantas N, Dauge G, Brazaitis M. Sex-related differences in fine motor skills and muscle strength control during short-term fasting. Sci Rep. 2026 Jan 3;16(1):4245. doi: 10.1038/s41598-025-34354-z.
PubMed 41484413Solianik R, Zidoniene K, Baranauskiene N, Brazaitis M. Fasting for 48 h induced similar glucose intolerance in both sexes despite greater perceived stress and decreased estradiol levels in females. Eur J Appl Physiol. 2024 May;124(5):1449-1459. doi: 10.1007/s00421-023-05378-y. Epub 2023 Dec 18.
PubMed 38108909
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2-day and 6-day Calorie Restriction and Whole-body Cooling Strategies on Health-related Indicators, Cognitive and Motor Functions
- ClinicalTrials.gov ID
- NCT05545943
- Acronym / sponsor ID
- LithuanianSportsU-10
- Conditions
- Calorie Deficiency, Fasting, Cold Exposure
- Keywords
- cognition, motor function, metabolism, young adults, fasting, starvation, men, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders.
The main questions it aims to answer were:
- Does fasting duration have any effect on fasting evoked responses?
- Does cold interventions can modulate fasting evoked responses?
- Does sex have any effect on acute fasting evoked responses?
For the first part, participants were randomly classified into 4 groups: two experimental groups: 2-days of CR (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. For the second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. Changes in anthropometric characteristics, perceived stress, metabolism, overall health (total blood count, sex hormones, etc.), psycho-emotional state, cognitive and motor functions were examined.
Detailed description
The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders.
At first study part, participants were randomly classified into 4 groups: two experimental groups: 2-days of calorie restriction (CR) (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. In the experimental groups, the participants were instructed to follow a prescribed zero-calorie diet with water provided ad libitum over a period of 2 or 6 days. In the control groups, the participants were instructed to maintain their previous eating habits for 2 or 6 days. Body weight and composition, heart rate variability, pulmonary gas exchange, blood pressure, and body temperature were assessed. Subsequently, participants completed self-assessment questionnaires, and then saliva samples were collected for further cortisol and sex hormones analysis, also capillary and venous blood samples were taken for ketone, glucose, insulin, lipid profile, catecholamines, brain-derived neurotrophic factor, total antioxidant capacity, malondialdehyde, glucagon, interleukin-10, metabolites of the kynurenines pathway and complete blood count concentrations evaluation. Then, the manual dexterity, and the cognitive and neuromuscular functions were assessed. The same measurements were repeated before each trial, after each trial and after 1 week.
At second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. The same measurements described in first part were repeated before each and after each condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
- Model description
- This project consisted of two parts. For the first part was used randomized parallel model, and we aimed to investigate fasting duration effect, whereas for the second part was used randomized crossover model and we aimed to investigate if cold exposure can modify fasting evoked effects on health-related indicators, cognition and motor function.
| Arm | Type | Receives |
|---|---|---|
| 2-days of calorie restriction with whole body cooling | Experimental | Other: 2-days of zero calorie restriction and whole-body cold-water immersionHealthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) with two 10-min whole body cooling practices on separate days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data. |
| 6-days of calorie restriction | Experimental | Other: 6-days of calorie restrictionHealthy young subjects participated in 6-day CR (0 kcal with water provided ad libitum). All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data. |
| 2-days of the usual diet (control) | No intervention | –During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 2 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data. |
| 6 days of the usual diet (control) | No intervention | –During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data. |
| 2-days of calorie restriction without whole-body cooling | Experimental | Other: 2-days of zero calorie restriction without whole-body cold-water immersionHealthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) without whole body cooling. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data. |
| 2-days of usual diet with whole-body cooling | Active comparator | Other: 2-days of usual diet with whole-body cold-water immersionHealthy young subjects participated two 10-min whole body cooling practices on separate days and were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- body mass index 19.5-29.9 kg/m2,
- age 18-40 years,
- no excessive regular moderate or vigorous physical activity, i.e., ≥3 times per week,
- non-smokers,
- no medications that could affect the results of experiment,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-days of zero calorie restriction and whole-body cold-water immersionThe 2-days (48 hours) of zero-calorie restricted diet (with water provided ad libitum) with two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min. | Other | 2-days of calorie restriction with whole body cooling |
| 6-days of calorie restrictionThe 6-days (144 hours) of prescribed zero-calorie prescribed diet with water provided ad libitum. | Other | 6-days of calorie restriction |
| 2-days of zero calorie restriction without whole-body cold-water immersion2 days (48 hours) of prescribed zero-calorie diet with water provided ad libitum . | Other | 2-days of calorie restriction without whole-body cooling |
| 2-days of usual diet with whole-body cold-water immersionTwo whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min. During intervention, participants were instructed to maintain their previous eating habits. | Other | 2-days of usual diet with whole-body cooling |
Primary outcome
Change in body mass and body composition (kg)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Body mass and composition (in kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Change in body mass index (kg/m2)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.
Change in substrate oxidation
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Oxygen consumption and carbon dioxide output every 5 s on a breath-by breath basis using an Oxycon Mobile spirometry system (Oxygen Mobile, Jaeger/ VIASYS Healthcare, Germany) was measured at rest, and the respiratory quotient (RQ=VCO2/VO2) was computed to determine substrate utilisation. The RQ values for fat was assumed as 0.7, for protein was assumed as 0.8 and for carbohydrate was assumed as 1.0.
Change in energy expenditure (kcal/day)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Resting energy expenditure (REE) using Weir equation modified Weir equation: REE (kcal/day)=[3.941(oxygen consumption) + 1.106(carbon dioxide output)] x 1440
Change in body temperature (°C)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Rectal temperature (°C) was measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (°C) was measured with thermistors (Skin/Surface Probe, DM852, Ellab) at three sites: back, thigh, and forearm, and right lateral gastrocnemius muscle temperature (°C) was measured using a needle microprobe (MKA; Ellab).
Change in heart rate variability (ms)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
R-R intervals (in ms) in supine resting conditions were recorded using a Polar HR sensor (Finland) and and simultaneously transferred to Polar Pro Trainer 5 software (Finland).
Change in heart rate variability (time domain) (ms)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the time domain that reflects general heart rate variability (HRV), the standard deviation of normal-to-normal intervals (SDNN; estimate of overall HRV) and the root mean square of successive differences (RMSSD; estimate of short-term components of HRV) were assessed (in ms).
Change in heart rate variability (time domain) (Ln)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the time domain that reflects general heart rate variability (HRV), the standard deviation of normal-to-normal intervals (SDNN; estimate of overall HRV) and the root mean square of successive differences (RMSSD; estimate of short-term components of HRV) were assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Change in heart rate variability (frequency domain) (ms2)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in absolute units (in ms2).
Change in heart rate variability (frequency domain) (Ln)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers were assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Change in heart rate variability (frequency domain) (nu)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in normalized units (in nu).
Change in heart rate (bpm)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Heart rate (in bpm) was recorded using a heart rate sensor with a chest strap (Polar, Finland) in laying position at rest.
Change in blood pressure (mmHg)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Resting systolic and diastolic blood pressure (in mmHg) was measured using a digital electronic blood pressure monitor (Microlife, Switzerland)
Change in perceived stress
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Perceived stress was evaluated with visual analog scales (VAS) ranging from 0 ("no stress") to 100 ("the highest stress imaginable").according to how participants feel "right now".
Change in appetite sensations
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Appetite sensations (hunger and fullness) were evaluated with VAS ranging from 0 ("I am not hungry at all/not at all full") to 100 ("I have never been more hungry/totally full") according to how participants feel "right now".
Change in mood state
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Mood state was evaluated with Brunel mood scale according to how participants feel "right now". The scale consists of 24 items divided into six subscales: anger, confusion, depression, fatigue, tension, and vigor. The items are answered on a 5-point scale, and each subscale, with four relevant items, are summed to produce a raw score in the range of 0-16, where a higher score indicates greater endorsement of the specific mood state.
Change in venous complete blood count (10^9/L)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Venous complete blood count with 5 different white blood count (WBC) components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10^9/L) was performed using an automated Mythic 60 hematology analyzer (Switzerland).
Change in venous complete blood count (%)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Venous complete blood count with 5 different white blood count (WBC) components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in %) was performed using an automated Mythic 60 hematology analyzer (Switzerland).
Change in serum female sex hormones concentration (pg/mL)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous serum 17beta-estradiol and progesterone (in pg/mL) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).
Change in serum female sex hormones concentration (mIU/ml)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous serum follicle stimulating and luteinizing hormones (in mIU/ml) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).
Change in serum brain-derived neurotrophic factor concentration (pg/ml)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous serum brain-derived neurotrophic factor (in pg/ml) was measured using enzyme-linked immunosorbent assay kits (Cat.No. DBD00; R\&D Systems, Emeryville, USA) and a Spark multimode microplate reader (Tecan, Austria).
Change in serum interleukin-10 concentration (pg/ml)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous serum interleukin (in pg/ml) was measured using enzyme-linked immunosorbent assay kits (Cat. No. 30147233; IBL International GmBH, Germany) and a Spark multimode microplate reader (Tecan, Austria).
Change in serum insulin concentration (μIU/ml)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous serum insulin concentrations (in μIU/ml) were measured using enzyme-linked immunosorbent assay kits (Cat. No. E-EL-H2237, Elabscience, China) and a Spark multimode microplate reader (Tecan, Austria).
Change in serum glucagon concentration (pg/ml)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous serum glucagon concentrations (in pg/ml) were measured using enzyme-linked immunosorbent assay kits (DIAsource ImmunoAssays S.A.,Belgium) and a Spark multimode microplate reader (Tecan, Austria).
Change in plasma catecholamines concentration (ng/ml)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous plasma adrenaline and noradrenaline concentrations (in ng/ml) were measured using enzyme-linked immunosorbent assay kits (Cat. No. RE59242, IBL International GmbH, Germany) and a Spark multimode microplate reader (Tecan, Austria).
Change in plasma malondialdehyde concentration (nmol/ml)
Time frame: Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery
The venous plasma malondialdehyde concentrations (in nmol/l) were measured using a solid phase nzyme-linked immunosorbent assay (Cat. No. E1371Hu, Bioassay Technology Laboratory, Shangai, China) and a Spark multimode microplate reader (Tecan, Austria).
Change in plasma total antioxidant capacity (mmol/l)
Time frame: Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery
The venous plasma total antioxidant capacitys (in mmol/l) were measured colorimetrically with an assay kit (Cat. No.E-BC-K271-M, Elabscience Biotechnology Inc, Houston, USA) and using a Spark multimode microplate reader (Tecan, Austria).
Change in venous glucose concentration (mmol/l)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The venous glucose concentration (in mmol/l) was measured in venous blood samples using a Glucocard X-mini plus glucose analyser (Arkray, Japan).
Change in insulin sensitivity
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
An oral glucose insulin sensitivity [OGIS] index derived from an oral glucose tolerance test was calculated.
Change in plasma metabolites of the kynurenine pathway (μm)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) to measure venous plasma levels of tryptophan, kynurenine, kynurenic acid, 3-hydroxy-kynurenine, quinolinic acid, nicotinamide and picolinic acid (in μm). The UPLC-MS/MS system used a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system was operated in electrospray positive multiple reaction monitoring mode.
Change in salivary cortisol concentration (µg/dl)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The saliva samples were collected to measure cortisol level (in µg/dl) using a enzyme-linked immunosorbent assay (ELISA) kits and a Spark multimode microplate reader (Tecan, Austria).
Change in salivary testosterone concentration (µg/dl)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The saliva samples were collected to measure testosterone level (in µg/dl) using a enzyme-linked immunosorbent assay (ELISA) kits and a Spark multimode microplate reader (Tecan, Austria).
Change in capillary lipid profile (mmol/l)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The capillary blood samples were collected from finger to measure lipid profile (in mmol/l) (total cholesterol, high density and low density cholesterol, triglycerides) using a CardioChek PA analyzer (USA).
Change in manual dexterity performance (sec)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The Grooved Pegboard was used to evaluate the ability to coordinate the fingers and manipulate objects promptly in time twice (in sec).
Change in information processing (μV)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany), event-related potentials (ERPs) during oddball tasks by two modalities (auditory and visual) were recorded. Peak amplitudes (μV) of the N1, N2 and P3 at three sites (Fz, Cz, and Pz) were defined.
Change in information processing (ms)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany), event-related potentials (ERPs) during oddball tasks by two modalities (auditory and visual) were recorded. Latencies (ms) of the N1, N2 and P3 at three sites (Fz, Cz, and Pz) were defined.
Change in brain neural network activity (µV2)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Resting electroencephalography was recorded using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany). Participant's data were averaged across the epochs for Fz, Cz and Pz electrodes, and mean absolute power (in µV2) was computed for theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz) frequency band.
Change in cognitive performance (ms)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Two oddball tasks were used in this study: in one task, visual stimuli were presented, and in the other task, auditory stimuli were presented. Reaction times (in ms) were measured.
Change in cognitive performance (%)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Two oddball tasks were used in this study: in one task, visual stimuli were presented, and in the other task, auditory stimuli were presented. Accuracy of response to the target stimulus (in %) were measured.
Change in reflexes (mV)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Soleus H-reflexes, V-waves and M-waves were evoked by 0.5 ms square-wave pulses using a high-voltage stimulator (Digitimer, UK). The amplitudes (in mV) of the electrical evoked reflexes were evaluated.
Change in reflexes (ms)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Soleus H-reflexes, V-waves and M-waves were evoked by 0.5 ms square-wave pulses using a high-voltage stimulator (Digitimer, UK). The latencies (in ms) of the electrical evoked reflexes were evaluated.
Change in muscle activity (mV)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Tibial muscles electromyographic (EMG) amplitude (in mV) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.
Change in muscle activity (Hz)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Tibial muscles electromyographic (EMG) frequency (in Hz) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.
Change in voluntary torque (Nm)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Isometric and isokinetic voluntary torques (in Nm) of the ankle plantar flexion/dorsiflexion muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).
Change in involuntary torque (Nm)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Involuntary torque of the ankle plantar flexion muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA) and a high-voltage stimulator (Digitimer DS7A, Digitimer, UK). Peak torques (in Nm) induced by electrical stimulation at 20 Hz,at 100 Hz, and at TT100 were measured.
Change in muscle contraction and relaxation (ms)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The contraction and half-relaxation time (in ms) were measured in resting TT100 contractions.
Change in central activation ratio (%)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
To evaluate central activation ratio (CAR), a TT-100 Hz stimuli was superimposed on the maximal voluntary contraction (MVC), and the CAR was computed using the following equation: CAR = MVC/(MVC+TT-100 Hz) × 100%, where where a CAR of 100% indicates complete activation of the exercising muscle and a CAR < 100% indicates central activation failure or inhibition.
Change in reactive strength
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate reactive-strength. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Reactive strength index as jump height / time to take off was calculated.
Change in jump performance (cm)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate jump performance. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Jump height (in cm) height was evaluated.
Change in jump performance (m/s)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate jump performance. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Time to take off (in m/s) was evaluated.
8 secondary outcomes
Change in height (m)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in skinfold thickness (mm)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in body fatness (%)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in physical activity (Step count)
Time frame: 3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)
Change in sleep (h)
Time frame: 3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)]
Change in oxygen consumption and carbon dioxide output (ml/min)
Time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Change in capillary blood ketone concentrations (mmol/l)
Time frame: Pre-condition, 24, 48 or 144 hours post-condition, and 1 week after recovery
Change in capillary blood glucose concentrations (mmol/L)
Time frame: Pre-condition, 24, 48 or 144 hours post-condition, and 1 week after recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 42323358Solianik R, Eimantas N, Dauge G, Brazaitis M. The effect of 6-day fasting on physical performance and neuromuscular control in healthy men. Sci Rep. 2026 Jun 20. doi: 10.1038/s41598-026-57312-9. Online ahead of print.
- Derived from this study: PubMed 41484413Solianik R, Eimantas N, Dauge G, Brazaitis M. Sex-related differences in fine motor skills and muscle strength control during short-term fasting. Sci Rep. 2026 Jan 3;16(1):4245. doi: 10.1038/s41598-025-34354-z.
- Derived from this study: PubMed 38108909Solianik R, Zidoniene K, Baranauskiene N, Brazaitis M. Fasting for 48 h induced similar glucose intolerance in both sexes despite greater perceived stress and decreased estradiol levels in females. Eur J Appl Physiol. 2024 May;124(5):1449-1459. doi: 10.1007/s00421-023-05378-y. Epub 2023 Dec 18.
- Individual participant dataSharing planned: No
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Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
Parenteral Nutrition, Gastroparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katerina Židonienė principal investigator
Lithuanian Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-days of zero calorie restriction and whole-body cold-water immersion, 6-days of calorie restriction and 2-days of zero calorie restriction without whole-body cold-water immersion in people with Calorie Deficiency and Fasting, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass and body composition (kg) (time frame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery). The study lists 50 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545943, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.