HealthyNCT06346639
Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators
A study testing 16-day hot and cold acclimation in people with Healthy, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 16-day hot and cold acclimation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteLithuania
- Study dates
- 4 Apr 2024to 4 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young, healthy, non-obese males and females;
- nonsmoker;
- no needle phobia;
- not taking medication and/or dietary supplements that may affect experimental variables.
Who cannot join
- neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to acute thermal stimuli and that could affect experimental variables;
- involvement in temperature manipulation program for ≥ 3 months;
- attendance at any excessive formal physical exercise or sports program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian Sports University
Kaunas, LT-44221
Diana Reklaitienė, PhD
About this study
Official title: Time Course of Adaptive Responses in Humans During a 16-day Hot and Cold Acclimation Program, and Its Effect on Health-related Indicators
There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers.
- Conditions
- Healthy
- Being tested
- 16-day hot and cold acclimation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-day hot and cold acclimationOther
Acclimation program will consist of 8 brief cold water immersions (CWI; 14°C 5 min) and 8 hot water immersions (HWI; 45°C 5 min). Heat and cold sessions will be performed on separate days (i.e., 1st day hot exposure, 2nd day cold exposure, 3rd day hot exposure, etc.).
| Study group | Role | What they receive |
|---|---|---|
| 16-day hot and cold acclimation | Experimental | Healthy young subjects will participate in a 16-days hot and cold acclimation program. During cold procedure, the participant will be immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 5-min, and during hot procedure, the participant will be immersed in 45° water bath in semi recumbent position up to the level of the manubrium for 5-min. Receives: Other: 16-day hot and cold acclimation |
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) will be evaluated using Tanita Body Composition Analyzer (Japan).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in skinfold thickness (mm)
Skinfolds thickness (in mm) will be measured using a skinfold caliper (Saehan, Korea) at 10 sites and the mean subcutaneous fat thickness will be calculated.
Measured: Before acclimation (1st day), 2 days and 2 weeks after the end of acclimation (44 th and 51st day)
Change in body mass index (kg/m^2)
The body mass index (in kg/m^2) will be defined as the body mass divided by the square of the body height.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in body surface area (m^2)
The participant's body surface area (BSA) (in m^2) will be estimated using the following equations: BSA = 128.1 ×weight^0.44 × height^0.60 for males and BSA = 147.4 ×weight^0.47 × height^0.55 for females.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in substrate oxidation
Oxygen consumption (VO2) and carbon dioxide (VCO2) output will be measured using Cortex METALYZR® 3B, Leipcig, Germany), and the respiratory quotient (RQ = VCO2 / VO2) will be computed to determine substrate utilisation. The RQ values for fat is assumed as 0.7, for protein is assumed as 0.8 and for carbohydrate isassumed as 1.0.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in substrate oxidation (g/day)
Carbohydrate and fat oxidation (in g/day) will be measured using Cortex METALYZR® 3B, Leipcig, Germany).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in ventilation (l/min)
Ventilation (in l/min) will be measured using Cortex METALYZR® 3B, Leipcig, Germany).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in breathing frequency (t/min)
Breathing frequency (in t/min) will be measured using Cortex METALYZR® 3B, Leipcig, Germany).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in resting energy expenditure (kcal/day)
The resting energy expenditure (REE; in kcal/day) will be computed using the following equation: REE = [3.941 × (VO2) + 1.106 × (VCO2)] × 1440
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in metabolic heat production (W)
The metabolic heat production (MHP; in W) will be computed using the equation: MHP = (281.65 + 80.65 × RQ) × VO2.
Measured: during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)
Change in heart rate (bpm)
Heart rate (in bpm) will be recorded using a heart rate sensor with a chest strap (Polar, Finland) or Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in blood pressure (mmHg)
Systolic and diastolic blood pressure (in mmHg) will be measured using PROVIEW 10 Compact Patient Monitor (Germany).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in mean arterial pressure (mmHg)
The mean arterial pressure (MAP; in mmHg) will be estimated using the formula: MAP = DP + 1/3(SP - DP) or MAP = DP + 1/3(SP - DP), where SP is systolic bood pressure and DP is diastolic blood pressure.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in heart rate variability (ms)
R-R intervals (in ms) in supine resting will be recorded using a Polar heart ratesensor (Finland) and simultaneously transferred to Polar Pro Trainer 5 software (Finland)
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in heart rate variability (time domain) (ms)
Heart rate variability data will be analyzed using Kubios heart rate 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 will be assessed (in ms).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in heart rate variability (time domain) (Ln)
Heart rate variability data will be analyzed using Kubios heart rate 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) will be assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in heart rate variability (frequency domain) (ms^2)
Heart rate variability data will be analyzed using Kubios heart rate variability analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in absolute units (in m^2) will be assessed.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in heart rate variability (frequency domain) (Ln)
In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers will be assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in stroke volume (ml)
Stroke volume (in ml) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in stroke volume index (ml/m^2)
Stroke volume index (in ml/m^2) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in cardiac output index (l/min//m^2)
Cardiac output (in l/min/m^2) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in cardiac output index (l/min)
Cardiac output (in l/min) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in contractility index
Contractility index will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in ventricular ejection time (ms)
Ventricular ejection time (in ms) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in ventricular ejection fraction (percent)
Ejection fraction (in percent) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in end diastolic volume (ml)
End diastolic volume (in ml) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in systemic vascular resistance (dyn.s/cm5.m^2)
Systemic vascular resistance (in dyn.s/cm5.m^2) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in cardiac work index (kg.m/m^2)
Cardiac work index (in kg.m/m^2) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in early diastolic filling ratio (percent)
Early diastolic filling ratio (in percent) will be recorded using Physioflow hemodynamic monitor (France).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in testosterone concentration (µg/dl)
The saliva samples will be collected to measure testosterone level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in female sex hormones concentration (pg/mL)
The venous 17beta-estradiol and progesterone (in pg/mL), follicle stimulating hormone and luteinizing hormone will be measured using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in salivary cortisol concentration (µg/dl)
The saliva samples will be collected to measure cortisol level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria)..
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in cytokines concentrations (pg/ml)
The venous tumor necrosis factor alpha, interleukin-6 and IL-1 beta (in pg/ml) will be measured using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in complete blood count (10^9/L)
Complete blood count with 5 different white blood count components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10^9/L) will be performed using an automated Mythic 60 hematology analyzer (Switzerland).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in complete blood count (percent)
Complete blood count with 5 different white blood count components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in percent) will be performed using an automated Mythic 60 hematology analyzer (Switzerland).
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in lipid profile (mmol/l)
Blood samples will be collected to measure lipid profile (in mmol/l) (total cholesterol, high density and low density cholesterol, triglycerides) using a CardioChek PA analyzer (USA).
Measured: Before acclimation (1st day),during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in catecholamines concentration (ng/ml)
The venous adrenaline and noradrenaline concentrations (in ng/ ml) will be measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).
Measured: Before acclimation (1st day),during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in insulin concentration (μIU/ml)
The venous insulin concentrations (in μIU/ml) will be measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria)
Measured: Before acclimation (1st day), 2nd day and 2 weeks after the end of acclimation (44th and 51st days)
Change in glucose tolerance (mmol/l)
The glucose concentration (in mmol/l) will be measured using a On-call GK dual meter (Acon Laboratories, USA).
Measured: Before acclimation (1st day), 2nd day and 2 weeks after the end of acclimation (44th and 51st days)
Change in anxiety and depression (points)
The level of anxiety and depression (in points) will be defined using Hospital Anxiety and Depression scale. Scale scores range from 0 to 21, with higher scores indicating more severe symptoms.
Measured: Before acclimation (1st day), 2nd day and 2 weeks after the end of acclimation (44th and 51st days)
Change in plasma metabolites of the kynurenine pathway (μm)
An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) will be used 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 uses a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system operates in electrospray positive multiple reaction monitoring mode.
Measured: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in body temperature (°C)
Rectal temperature (in °C) will be measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (in °C) will be measured with thermistors (Skin/Surface Probe, DM852, Ellab) at four sites: supraclavicular, back, thigh, and forearm, and right lateral gastrocnemius muscle temperature (in °C) will be measured using a needle microprobe (MKA; Ellab).
Measured: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Change in physiological strain index
A physiological strain index (PSI) will be used to indicate heat strain. PSI = 5 x (Tret - Tre0) x (39.5 - Tre0)^-1+ 5 x (HRt - HR0) x (180 - HR0)^-1, where rectal temperature (Tre) t and heart rate (HR) t are simultaneous measurements taken at the end of the heat exposure and Tre0 and HR0 are the initial measurements.
Measured: During baseline provocative heat test (8th or 15th day), during acclimation (from 22 to 37th days), during repeated provocative heat test (41st or 42nd days)
Change in cold strain index
A cold strain index (CSI) will be used to indicate cold strain. CSI = 6.67 x (Tre t - Tre 0) x (35 - Tre 0)^-1 + 3.33 x (Tsk t - Tsk 0) x (20 - Tsk 0)^-1, where rectal temperature (Tre) 0 and skin temperature (Tsk) 0 are initial measurements and Tre t and Tsk t are simultaneous measurements taken at the end of the cold exposure.
Measured: During baseline provocative cold test (8th or 15th day), during acclimation (from 22 to 37th days), during repeated provocative cold test (41st or 42nd days)
Change in root mean square (RMS) amplitude (mV)
Root mean square (RMS) amplitude (in mV) of pectoralis major muscle indicating shivering intensity will be measured using a surface EMG (Biometrics, UK).
Measured: During baseline provocative cold test (8th or 15th day), during acclimation (from 22 to 37th days), during repeated provocative cold test (41st or 42nd day)
Change in pain sensations
The pain sensation will be evaluated using numeric pain scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
Change in thermal sensations (points)
The thermal sensation will be evaluated using 9-point scale. The rating of thermal sensation range from 1 (very cold) to 9 (very hot), with 5 being neutral.
Measured: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
Change in shivering/sweating (points)
The shivering/sweating rate will be evaluated using 7-point scale. The rating of shivering/sweating range from 1 (heavily sweating) to 7 (vigorously shivering), with 4 being neutral.
Measured: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
Change in thermal comfort (points)
The thermal comfort will be evaluated using 4-point scale. The rating of thermal comfort range from 0 (neutral) to 3 (very uncomfortable).
Measured: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
Secondary outcomes (4)
Height (m)
Height (in m) will be measured using a Harpenden anthropometer set (Holtain Ltd, UK)
Measured: Before acclimation (1st day)
Change in physical activity (in h)
MotionWatch 8 actigraph will estimate the time spent in sedentary, light, moderate, or vigorous activity
Measured: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.
Change in sleep (in h)
Sleep statistics (in h) including total hours of sleep and the time spent in different sleep stages will be assessed with MotionWatch 8 actigraph.
Measured: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.
Change in oxygen saturation (percent)
Oxygen saturation (in percent) will be measured using Proview 10 Compact Patient Monitor (Germany).
Measured: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start4 Apr 2024
- Primary completion4 Apr 2029 (estimated)
- Study completion4 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Jarutienė, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346639
- Sponsor's protocol ID
- LithuananianSportsU-17
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Adaptive Responses in Humans During a 16-day Hot and Cold Acclimation Program, and Its Effect on Health-related Indicators
- ClinicalTrials.gov ID
- NCT06346639
- Acronym / sponsor ID
- LithuananianSportsU-17
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Apr 2029 (estimated)
- Study completion
- 4 Apr 2029 (estimated)
- First posted
- 4 Apr 2024 (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.
There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16-day hot and cold acclimation | Experimental | Other: 16-day hot and cold acclimationHealthy young subjects will participate in a 16-days hot and cold acclimation program. During cold procedure, the participant will be immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 5-min, and during hot procedure, the participant will be immersed in 45° water bath in semi recumbent position up to the level of the manubrium for 5-min. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- young, healthy, non-obese males and females;
- nonsmoker;
- no needle phobia;
- not taking medication and/or dietary supplements that may affect experimental variables.
Key exclusion criteria (3 listed)
- neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to acute thermal stimuli and that could affect experimental variables;
- involvement in temperature manipulation program for ≥ 3 months;
- attendance at any excessive formal physical exercise or sports program.
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 |
|---|---|---|
| 16-day hot and cold acclimationAcclimation program will consist of 8 brief cold water immersions (CWI; 14°C 5 min) and 8 hot water immersions (HWI; 45°C 5 min). Heat and cold sessions will be performed on separate days (i.e., 1st day hot exposure, 2nd day cold exposure, 3rd day hot exposure, etc.). | Other | 16-day hot and cold acclimation |
Primary outcome
Change in body mass and body composition (kg)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Body mass and composition (in kg) will be evaluated using Tanita Body Composition Analyzer (Japan).
Change in skinfold thickness (mm)
Time frame: Before acclimation (1st day), 2 days and 2 weeks after the end of acclimation (44 th and 51st day)
Skinfolds thickness (in mm) will be measured using a skinfold caliper (Saehan, Korea) at 10 sites and the mean subcutaneous fat thickness will be calculated.
Change in body mass index (kg/m^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The body mass index (in kg/m^2) will be defined as the body mass divided by the square of the body height.
Change in body surface area (m^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The participant's body surface area (BSA) (in m^2) will be estimated using the following equations: BSA = 128.1 ×weight^0.44 × height^0.60 for males and BSA = 147.4 ×weight^0.47 × height^0.55 for females.
Change in substrate oxidation
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Oxygen consumption (VO2) and carbon dioxide (VCO2) output will be measured using Cortex METALYZR® 3B, Leipcig, Germany), and the respiratory quotient (RQ = VCO2 / VO2) will be computed to determine substrate utilisation. The RQ values for fat is assumed as 0.7, for protein is assumed as 0.8 and for carbohydrate isassumed as 1.0.
Change in substrate oxidation (g/day)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Carbohydrate and fat oxidation (in g/day) will be measured using Cortex METALYZR® 3B, Leipcig, Germany).
Change in ventilation (l/min)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Ventilation (in l/min) will be measured using Cortex METALYZR® 3B, Leipcig, Germany).
Change in breathing frequency (t/min)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Breathing frequency (in t/min) will be measured using Cortex METALYZR® 3B, Leipcig, Germany).
Change in resting energy expenditure (kcal/day)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The resting energy expenditure (REE; in kcal/day) will be computed using the following equation: REE = [3.941 × (VO2) + 1.106 × (VCO2)] × 1440
Change in metabolic heat production (W)
Time frame: during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)
The metabolic heat production (MHP; in W) will be computed using the equation: MHP = (281.65 + 80.65 × RQ) × VO2.
Change in heart rate (bpm)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Heart rate (in bpm) will be recorded using a heart rate sensor with a chest strap (Polar, Finland) or Physioflow hemodynamic monitor (France).
Change in blood pressure (mmHg)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Systolic and diastolic blood pressure (in mmHg) will be measured using PROVIEW 10 Compact Patient Monitor (Germany).
Change in mean arterial pressure (mmHg)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The mean arterial pressure (MAP; in mmHg) will be estimated using the formula: MAP = DP + 1/3(SP - DP) or MAP = DP + 1/3(SP - DP), where SP is systolic bood pressure and DP is diastolic blood pressure.
Change in heart rate variability (ms)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
R-R intervals (in ms) in supine resting will be recorded using a Polar heart ratesensor (Finland) and simultaneously transferred to Polar Pro Trainer 5 software (Finland)
Change in heart rate variability (time domain) (ms)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Heart rate variability data will be analyzed using Kubios heart rate 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 will be assessed (in ms).
Change in heart rate variability (time domain) (Ln)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Heart rate variability data will be analyzed using Kubios heart rate 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) will be assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Change in heart rate variability (frequency domain) (ms^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Heart rate variability data will be analyzed using Kubios heart rate variability analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in absolute units (in m^2) will be assessed.
Change in heart rate variability (frequency domain) (Ln)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers will be assessed and logarithmically transformed (Ln) to correct the skewness of distribution.
Change in stroke volume (ml)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Stroke volume (in ml) will be recorded using Physioflow hemodynamic monitor (France).
Change in stroke volume index (ml/m^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Stroke volume index (in ml/m^2) will be recorded using Physioflow hemodynamic monitor (France).
Change in cardiac output index (l/min//m^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Cardiac output (in l/min/m^2) will be recorded using Physioflow hemodynamic monitor (France).
Change in cardiac output index (l/min)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Cardiac output (in l/min) will be recorded using Physioflow hemodynamic monitor (France).
Change in contractility index
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Contractility index will be recorded using Physioflow hemodynamic monitor (France).
Change in ventricular ejection time (ms)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Ventricular ejection time (in ms) will be recorded using Physioflow hemodynamic monitor (France).
Change in ventricular ejection fraction (percent)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Ejection fraction (in percent) will be recorded using Physioflow hemodynamic monitor (France).
Change in end diastolic volume (ml)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
End diastolic volume (in ml) will be recorded using Physioflow hemodynamic monitor (France).
Change in systemic vascular resistance (dyn.s/cm5.m^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Systemic vascular resistance (in dyn.s/cm5.m^2) will be recorded using Physioflow hemodynamic monitor (France).
Change in cardiac work index (kg.m/m^2)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Cardiac work index (in kg.m/m^2) will be recorded using Physioflow hemodynamic monitor (France).
Change in early diastolic filling ratio (percent)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Early diastolic filling ratio (in percent) will be recorded using Physioflow hemodynamic monitor (France).
Change in testosterone concentration (µg/dl)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The saliva samples will be collected to measure testosterone level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).
Change in female sex hormones concentration (pg/mL)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The venous 17beta-estradiol and progesterone (in pg/mL), follicle stimulating hormone and luteinizing hormone will be measured using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).
Change in salivary cortisol concentration (µg/dl)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The saliva samples will be collected to measure cortisol level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria)..
Change in cytokines concentrations (pg/ml)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The venous tumor necrosis factor alpha, interleukin-6 and IL-1 beta (in pg/ml) will be measured using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).
Change in complete blood count (10^9/L)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Complete blood count with 5 different white blood count components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10^9/L) will be performed using an automated Mythic 60 hematology analyzer (Switzerland).
Change in complete blood count (percent)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Complete blood count with 5 different white blood count components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in percent) will be performed using an automated Mythic 60 hematology analyzer (Switzerland).
Change in lipid profile (mmol/l)
Time frame: Before acclimation (1st day),during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Blood samples will be collected to measure lipid profile (in mmol/l) (total cholesterol, high density and low density cholesterol, triglycerides) using a CardioChek PA analyzer (USA).
Change in catecholamines concentration (ng/ml)
Time frame: Before acclimation (1st day),during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
The venous adrenaline and noradrenaline concentrations (in ng/ ml) will be measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).
Change in insulin concentration (μIU/ml)
Time frame: Before acclimation (1st day), 2nd day and 2 weeks after the end of acclimation (44th and 51st days)
The venous insulin concentrations (in μIU/ml) will be measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria)
Change in glucose tolerance (mmol/l)
Time frame: Before acclimation (1st day), 2nd day and 2 weeks after the end of acclimation (44th and 51st days)
The glucose concentration (in mmol/l) will be measured using a On-call GK dual meter (Acon Laboratories, USA).
Change in anxiety and depression (points)
Time frame: Before acclimation (1st day), 2nd day and 2 weeks after the end of acclimation (44th and 51st days)
The level of anxiety and depression (in points) will be defined using Hospital Anxiety and Depression scale. Scale scores range from 0 to 21, with higher scores indicating more severe symptoms.
Change in plasma metabolites of the kynurenine pathway (μm)
Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) will be used 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 uses a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system operates in electrospray positive multiple reaction monitoring mode.
Change in body temperature (°C)
Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)
Rectal temperature (in °C) will be measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (in °C) will be measured with thermistors (Skin/Surface Probe, DM852, Ellab) at four sites: supraclavicular, back, thigh, and forearm, and right lateral gastrocnemius muscle temperature (in °C) will be measured using a needle microprobe (MKA; Ellab).
Change in physiological strain index
Time frame: During baseline provocative heat test (8th or 15th day), during acclimation (from 22 to 37th days), during repeated provocative heat test (41st or 42nd days)
A physiological strain index (PSI) will be used to indicate heat strain. PSI = 5 x (Tret - Tre0) x (39.5 - Tre0)^-1+ 5 x (HRt - HR0) x (180 - HR0)^-1, where rectal temperature (Tre) t and heart rate (HR) t are simultaneous measurements taken at the end of the heat exposure and Tre0 and HR0 are the initial measurements.
Change in cold strain index
Time frame: During baseline provocative cold test (8th or 15th day), during acclimation (from 22 to 37th days), during repeated provocative cold test (41st or 42nd days)
A cold strain index (CSI) will be used to indicate cold strain. CSI = 6.67 x (Tre t - Tre 0) x (35 - Tre 0)^-1 + 3.33 x (Tsk t - Tsk 0) x (20 - Tsk 0)^-1, where rectal temperature (Tre) 0 and skin temperature (Tsk) 0 are initial measurements and Tre t and Tsk t are simultaneous measurements taken at the end of the cold exposure.
Change in root mean square (RMS) amplitude (mV)
Time frame: During baseline provocative cold test (8th or 15th day), during acclimation (from 22 to 37th days), during repeated provocative cold test (41st or 42nd day)
Root mean square (RMS) amplitude (in mV) of pectoralis major muscle indicating shivering intensity will be measured using a surface EMG (Biometrics, UK).
Change in pain sensations
Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
The pain sensation will be evaluated using numeric pain scale ranging from 0 (no pain) to 10 (worst possible pain).
Change in thermal sensations (points)
Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
The thermal sensation will be evaluated using 9-point scale. The rating of thermal sensation range from 1 (very cold) to 9 (very hot), with 5 being neutral.
Change in shivering/sweating (points)
Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
The shivering/sweating rate will be evaluated using 7-point scale. The rating of shivering/sweating range from 1 (heavily sweating) to 7 (vigorously shivering), with 4 being neutral.
Change in thermal comfort (points)
Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st or 42nd day)
The thermal comfort will be evaluated using 4-point scale. The rating of thermal comfort range from 0 (neutral) to 3 (very uncomfortable).
4 secondary outcomes
Height (m)
Time frame: Before acclimation (1st day)
Change in physical activity (in h)
Time frame: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.
Change in sleep (in h)
Time frame: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.
Change in oxygen saturation (percent)
Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Laura Jarutienė 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 16-day hot and cold acclimation in people with Healthy, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Jarutienė (+37069009956, laura.jarutiene@stud.lsu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass and body composition (kg) (time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.