Dietary ExposureNCT06498102
Time-restricted Feeding Improves Basal Fat Oxidation and Body Composition But Not Fat Oxidation During Exercise
A study testing Intermittent Fasting: Time Restricted Feeding During 6 Weeks in people with Dietary Exposure, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Time-restricted feeding is one of the IF models with significant advantages beyond other IF models, such as simplicity and flexibility, where individuals limit their eating window to specific hours of the day, with a fasting period of at least 12 hours. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Intermittent Fasting: Time Restricted Feeding During 6 Weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 12 Dec 2023
- 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy recreationally active males who habitually undergo cycling, running, soccer 2-3 times per week volunteered to participate in this randomized controlled study.
Who cannot join
- Acute or chronic disease
- Taking any drug or supplements known to affect metabolism
- currently following time-restricted diets
- had lost more than 10% of their weight in the last 3 months before participated the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Sports Science, Hacettepe University
Ankara, 06100
About this study
Official title: Six Weeks of Time-restricted Feeding Improves Basal Fat Oxidation and Body Composition But Not Fat Oxidation During Exercise in Young Males: A Randomized Controlled Trial
Time-restricted feeding is one of the IF models with significant advantages beyond other IF models, such as simplicity and flexibility, where individuals limit their eating window to specific hours of the day, with a fasting period of at least 12 hours. Ample evidence in humans suggests that prolonged daily cycles of feeding and fasting when aligned with the circadian rhythm, as in the TRF regimen, can alleviate metabolic diseases. Furthermore, research supports a range of health benefits associated with TRF programs in diverse populations, including improvements in body composition and insulin sensitivity, appetite regulation, and achieving a more balanced hunger sensation. Moreover, adopting a 6-hour eating window followed by an 18-hour fasting period can elicit a metabolic shift from relying on glucose to utilizing ketones for energy, which is associated with extended lifespan and a reduced risk of various diseases including type 2 diabetes and obesity. This study aimed to determine the effect of a 6-week TRF on resting and exercise substrate oxidation and changes in blood markers linked to cardiometabolic health.
Read the detailed description
The aim of this study was to determine the effects of a 6-week TRF program on resting and exercise substrate oxidation, and examine changes in body composition and blood markers linked to cardiometabolic health in recreationally active young males. It was hypothesized that compared to controls, TRF would improve body composition, blood markers associated with cardiometabolic health, and increase substrate oxidation during rest and exercise.
Experimental approach to the problem:
Participants reported to the laboratory on 4 separate occasions. Initially, a familiarization session for V̇O2max testing was conducted on a cycle ergometer. In the second visit, participants repeated V̇O2max test to determine their cardiorespiratory fitness, and this test created the intensity for the submaximal exercise test. A minimum of 48 hours after the V̇O2max test and an overnight fast, body composition, resting metabolic rate (RMR), and substrate oxidation during submaximal exercise were assessed. All measurements were performed between 08:00 a.m. and 12:00 noon in order to eliminate the effect of circadian rhythm. Subsequently, participants were randomly assigned to either TRF or control group. The TRF group received comprehensive nutrition education from a dietitian and was directed to adhere to the 16:8 program for 6 weeks, limiting their eating window to 8 hours daily, while the control group was asked to maintain their eating habits. To assess participant quality of life, the 12-item Short Form Health Survey (SF-12) developed by Ware et al. was administered before and after the 6-week intervention period (38). All participants were asked to maintain their daily physical activity levels throughout the study. A 7-day food diary was completed by all participants at study initiation and during the third and sixth week. After completing the six-week program, all participants underwent post-tests identical to the pre-tests. Venous blood samples were collected from all participants following an overnight fast at baseline and after 6 weeks.
- Conditions
- Dietary Exposure
- Being tested
- Intermittent Fasting: Time Restricted Feeding During 6 Weeks
- Keywords
- Diet, Intermittent Fasting, Exercise, Metabolism
- Medical subject headings
- Intermittent Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Fasting: Time Restricted Feeding During 6 WeeksOther
Thirty-one healthy, young males (age: 27.5±6 years, body mass: 76.5±8.4 kg, and maximal oxygen uptake [V̇O2max]: 43.9±6.6 mL/kg/min) were randomly assigned to either TRF (n=14) or control group (n=17). TRF group followed an 16:8 intermittent fasting diet program for 6 weeks. Body composition, insulin sensitivity, resting substrate oxidation, and fat oxidation during cycling at 40% V̇O2max were assessed before and after the diet program.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Feeding Group | Experimental | Thirty-one healthy, young males (age: 27.5±6 years, body mass: 76.5±8.4 kg, and maximal oxygen uptake [V̇O2max]: 43.9±6.6 mL/kg/min) were randomly assigned to either TRF (n=14) or control group (n=17). TRF group followed an 16:8 intermittent fasting diet program for 6 weeks. Body composition, insulin sensitivity, resting substrate oxidation, and fat oxidation during cycling at 40% V̇O2max were assessed before and after the diet program. Receives: Other: Intermittent Fasting: Time Restricted Feeding During 6 Weeks |
| Control Group | No intervention | Control group maintained their existing dietary habits during the 6 weeks. Body composition, insulin sensitivity, resting substrate oxidation, and fat oxidation during cycling at 40% V̇O2max were assessed before and after the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of body composition (in kg) with Dual-energy X-ray absorptiometry (DXA)
All participants underwent a whole-body composition scan with light clothing to measure total body mass (kg), fat mass (kg), fat-free mass (kg), and lean body mass (kg), with an automatically chosen scanning mode by the DXA machine (Lunar Prodigy Pro Narrow Fan Beam (4.5º), GE Health Care, Madison, Wisconsin, USA).
Measured: 9 months
V̇O2max measurement
Participants' V̇O2max was determined using an incremental exercise test on a cycle ergometer (COSMED E 200, Rome, Italy). The test consisted of 2 minutes of cycling at 60 W, 120 W, and 150 W, respectively. Afterward, the workload increased by 30 W every minute until voluntary exhaustion. Heart rate (HR) was continuously recorded during the test using a HR monitor. Breath-by-breath expired air was acquired throughout the test using an online gas analysis system (Quark Cardio Pulmonary Exercise Testing, COSMED, Rome, Italy). The gas analyzer was periodically calibrated according to the manufacturer's procedures prior to each test. The recorded value for V̇O2max was the highest achieved over a 30-second sampling period.
Measured: 9 months
Measurement of resting metabolic rate (RMR)
RMR was determined using a breath-by-breath indirect system (CPET, Rome, Italy). Participants were required to fast for 10-12 hours before testing and limit physical activity on their way to the laboratory. Upon arriving at the laboratory, participants rested in a dimly lit, temperature-controlled room in a supine position, and were instructed to relax without falling asleep. The protocol involved a 20-minute rest in the supine position, followed by a 15-minute period of respiratory gas analysis. During the respiratory gas analysis, oxygen uptake and carbon dioxide output were measured using a breath-by-breath system with a breathing mask connected to a pre-calibrated computerized gas analyzer.
Measured: 9 months
Calculation of resting substrate oxidation
We used the respiratory data (oxygen and carbon dioxide) collected during the RMR measurement to calculate resting fat (g/min) and resting carbohydrate oxidation (g/min) using the Frayn equation, as follows:
Fat oxidation (g/min) = 1,67 × V̇O2 (L/min) - 1,67 × V̇CO2 (L/min) CHO oxidation (g/min) = 4,55 × V̇CO2 (L/min) - 3,21 × V̇O2 (L/min)
Measured: 9 months
Measurement of substrate oxidation during submaximal exercise
A few minutes after RMR assessment, participants cycled for 30 minutes at a workload corresponding to 40% of their pre-determined V̇O2max on cycle ergometer (COSMED E 200, Italy) before and after the TRF program. The test commenced with a 3-minute warm-up at 60 W. V̇O2 and V̇CO2 during the test were recorded using an online gas analysis system (Quark Cardio Pulmonary Exercise Testing, COSMED, Rome, Italy). Fat oxidation and CHO oxidation were computed utilizing the equation proposed by Jeukendrup and Wallis.
Measured: 9 months
Food Diary
All participants completed a 7-day food diary at the commencement of the study, during the third week, and at the end of the sixth week to assess any potential changes in participant dietary habits. An experienced dietician determined the portion size with household units, such as cups, pieces, or plates. In addition, the ingredients of mixed dishes were specified, and product name and standard weights of food items were used to calculate serving sizes. All the results were calculated and analyzed by the same experienced dietician using Nutrition Information System (BEBIS 6.1, Dr. J. Erhardt, Stutgart, Hohenheim, Germany).
Measured: 9 months
Time Restricted Feeding
The TRF group received detailed nutrition education before the TRF program, and was instructed to follow the 16:8 program for six weeks, limiting their eating window to 8 hours daily (10:00 to 18:00 or alternatively 11:00 to 19:00), during which no calorie restriction was applied. During the 16-hour fasting window, the TRF group was asked to avoid calorie-containing foods and beverages. All participants in both groups were contacted twice a week to monitor dietary compliance in the TRF group and to maintain their existing eating habits in the control group.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start6 Jun 2022
- Primary completion20 May 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dietary ExposureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Control (n=17) and time-restricted feeding (TRF) group (n=17) Thirty-four healthy recreationally active males who habitually undergo cycling, running, soccer 2-3 times per week volunteered to participate in this randomized controlled study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Mustafa Atakan, Hacettepe University
- Investigators
- Muhammed Atakan, PhD, Study director, Hacettepe UniversityHale Aktaş, MSc, Study chair, Hacettepe UniversityHüseyin Turnagöl, Professor, Principal investigator, Hacettepe UniversityNazan Koşar, Proffesor, Study chair, Hacettepe UniversityZeynep Ergün, BsC, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498102
- Sponsor's protocol ID
- HU-SB-HA-02
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stratton MT, Tinsley GM, Alesi MG, Hester GM, Olmos AA, Serafini PR, Modjeski AS, Mangine GT, King K, Savage SN, Webb AT, VanDusseldorp TA. Four Weeks of Time-Restricted Feeding Combined with Resistance Training Does Not Differentially Influence Measures of Body Composition, Muscle Performance, Resting Energy Expenditure, and Blood Biomarkers. Nutrients. 2020 Apr 17;12(4):1126. doi: 10.3390/nu12041126.
PubMed 32316561Mattson MP, Allison DB, Fontana L, Harvie M, Longo VD, Malaisse WJ, Mosley M, Notterpek L, Ravussin E, Scheer FA, Seyfried TN, Varady KA, Panda S. Meal frequency and timing in health and disease. Proc Natl Acad Sci U S A. 2014 Nov 25;111(47):16647-53. doi: 10.1073/pnas.1413965111. Epub 2014 Nov 17.
PubMed 25404320Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
PubMed 27885007Di Francesco A, Di Germanio C, Bernier M, de Cabo R. A time to fast. Science. 2018 Nov 16;362(6416):770-775. doi: 10.1126/science.aau2095.
PubMed 30442801Atakan MM, Guzel Y, Bulut S, Kosar SN, McConell GK, Turnagol HH. Six high-intensity interval training sessions over 5 days increases maximal oxygen uptake, endurance capacity, and sub-maximal exercise fat oxidation as much as 6 high-intensity interval training sessions over 2 weeks. J Sport Health Sci. 2021 Jul;10(4):478-487. doi: 10.1016/j.jshs.2020.06.008. Epub 2020 Jun 18.
PubMed 32565243Atakan MM, Guzel Y, Shrestha N, Kosar SN, Grgic J, Astorino TA, Turnagol HH, Pedisic Z. Effects of high-intensity interval training (HIIT) and sprint interval training (SIT) on fat oxidation during exercise: a systematic review and meta-analysis. Br J Sports Med. 2022 Jul 20:bjsports-2021-105181. doi: 10.1136/bjsports-2021-105181. Online ahead of print.
PubMed 35859145Atakan MM, Kosar SN, Turnagol HH. Six Sessions of Low-volume High-intensity Interval Exercise Improves Resting Fat Oxidation. Int J Sports Med. 2022 Dec;43(14):1206-1213. doi: 10.1055/a-1905-7985. Epub 2022 Jul 20.
PubMed 35858638Xie Z, Sun Y, Ye Y, Hu D, Zhang H, He Z, Zhao H, Yang H, Mao Y. Randomized controlled trial for time-restricted eating in healthy volunteers without obesity. Nat Commun. 2022 Feb 22;13(1):1003. doi: 10.1038/s41467-022-28662-5.
PubMed 35194047Aktas H, Atakan MM, Aktitiz S, Ergun Z, Kosar SN, Astorino TA, Turnagol HH. Six weeks of time-restricted eating improves basal fat oxidation and body composition but not fat oxidation during exercise in young males. Clin Nutr. 2025 Jul;50:92-103. doi: 10.1016/j.clnu.2025.04.022. Epub 2025 Apr 30.
PubMed 40382896
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Weeks of Time-restricted Feeding Improves Basal Fat Oxidation and Body Composition But Not Fat Oxidation During Exercise in Young Males: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06498102
- Acronym / sponsor ID
- HU-SB-HA-02
- Conditions
- Dietary Exposure
- Keywords
- Diet, Intermittent Fasting, Exercise, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 12 Jul 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.
Time-restricted feeding is one of the IF models with significant advantages beyond other IF models, such as simplicity and flexibility, where individuals limit their eating window to specific hours of the day, with a fasting period of at least 12 hours. Ample evidence in humans suggests that prolonged daily cycles of feeding and fasting when aligned with the circadian rhythm, as in the TRF regimen, can alleviate metabolic diseases. Furthermore, research supports a range of health benefits associated with TRF programs in diverse populations, including improvements in body composition and insulin sensitivity, appetite regulation, and achieving a more balanced hunger sensation. Moreover, adopting a 6-hour eating window followed by an 18-hour fasting period can elicit a metabolic shift from relying on glucose to utilizing ketones for energy, which is associated with extended lifespan and a reduced risk of various diseases including type 2 diabetes and obesity. This study aimed to determine the effect of a 6-week TRF on resting and exercise substrate oxidation and changes in blood markers linked to cardiometabolic health.
Detailed description
The aim of this study was to determine the effects of a 6-week TRF program on resting and exercise substrate oxidation, and examine changes in body composition and blood markers linked to cardiometabolic health in recreationally active young males. It was hypothesized that compared to controls, TRF would improve body composition, blood markers associated with cardiometabolic health, and increase substrate oxidation during rest and exercise.
Experimental approach to the problem:
Participants reported to the laboratory on 4 separate occasions. Initially, a familiarization session for V̇O2max testing was conducted on a cycle ergometer. In the second visit, participants repeated V̇O2max test to determine their cardiorespiratory fitness, and this test created the intensity for the submaximal exercise test. A minimum of 48 hours after the V̇O2max test and an overnight fast, body composition, resting metabolic rate (RMR), and substrate oxidation during submaximal exercise were assessed. All measurements were performed between 08:00 a.m. and 12:00 noon in order to eliminate the effect of circadian rhythm. Subsequently, participants were randomly assigned to either TRF or control group. The TRF group received comprehensive nutrition education from a dietitian and was directed to adhere to the 16:8 program for 6 weeks, limiting their eating window to 8 hours daily, while the control group was asked to maintain their eating habits. To assess participant quality of life, the 12-item Short Form Health Survey (SF-12) developed by Ware et al. was administered before and after the 6-week intervention period (38). All participants were asked to maintain their daily physical activity levels throughout the study. A 7-day food diary was completed by all participants at study initiation and during the third and sixth week. After completing the six-week program, all participants underwent post-tests identical to the pre-tests. Venous blood samples were collected from all participants following an overnight fast at baseline and after 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups: Control (n=17) and time-restricted feeding (TRF) group (n=17) Thirty-four healthy recreationally active males who habitually undergo cycling, running, soccer 2-3 times per week volunteered to participate in this randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Feeding Group | Experimental | Other: Intermittent Fasting: Time Restricted Feeding During 6 WeeksThirty-one healthy, young males (age: 27.5±6 years, body mass: 76.5±8.4 kg, and maximal oxygen uptake [V̇O2max]: 43.9±6.6 mL/kg/min) were randomly assigned to either TRF (n=14) or control group (n=17). TRF group followed an 16:8 intermittent fasting diet program for 6 weeks. Body composition, insulin sensitivity, resting substrate oxidation, and fat oxidation during cycling at 40% V̇O2max were assessed before and after the diet program. |
| Control Group | No intervention | –Control group maintained their existing dietary habits during the 6 weeks. Body composition, insulin sensitivity, resting substrate oxidation, and fat oxidation during cycling at 40% V̇O2max were assessed before and after the program. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy recreationally active males who habitually undergo cycling, running, soccer 2-3 times per week volunteered to participate in this randomized controlled study.
Key exclusion criteria (4 listed)
- Acute or chronic disease
- Taking any drug or supplements known to affect metabolism
- currently following time-restricted diets
- had lost more than 10% of their weight in the last 3 months before participated the study
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 |
|---|---|---|
| Intermittent Fasting: Time Restricted Feeding During 6 WeeksThirty-one healthy, young males (age: 27.5±6 years, body mass: 76.5±8.4 kg, and maximal oxygen uptake [V̇O2max]: 43.9±6.6 mL/kg/min) were randomly assigned to either TRF (n=14) or control group (n=17). TRF group followed an 16:8 intermittent fasting diet program for 6 weeks. Body composition, insulin sensitivity, resting substrate oxidation, and fat oxidation during cycling at 40% V̇O2max were assessed before and after the diet program. | Other | Time Restricted Feeding Group |
Primary outcome
Measurement of body composition (in kg) with Dual-energy X-ray absorptiometry (DXA)
Time frame: 9 months
All participants underwent a whole-body composition scan with light clothing to measure total body mass (kg), fat mass (kg), fat-free mass (kg), and lean body mass (kg), with an automatically chosen scanning mode by the DXA machine (Lunar Prodigy Pro Narrow Fan Beam (4.5º), GE Health Care, Madison, Wisconsin, USA).
V̇O2max measurement
Time frame: 9 months
Participants' V̇O2max was determined using an incremental exercise test on a cycle ergometer (COSMED E 200, Rome, Italy). The test consisted of 2 minutes of cycling at 60 W, 120 W, and 150 W, respectively. Afterward, the workload increased by 30 W every minute until voluntary exhaustion. Heart rate (HR) was continuously recorded during the test using a HR monitor. Breath-by-breath expired air was acquired throughout the test using an online gas analysis system (Quark Cardio Pulmonary Exercise Testing, COSMED, Rome, Italy). The gas analyzer was periodically calibrated according to the manufacturer's procedures prior to each test. The recorded value for V̇O2max was the highest achieved over a 30-second sampling period.
Measurement of resting metabolic rate (RMR)
Time frame: 9 months
RMR was determined using a breath-by-breath indirect system (CPET, Rome, Italy). Participants were required to fast for 10-12 hours before testing and limit physical activity on their way to the laboratory. Upon arriving at the laboratory, participants rested in a dimly lit, temperature-controlled room in a supine position, and were instructed to relax without falling asleep. The protocol involved a 20-minute rest in the supine position, followed by a 15-minute period of respiratory gas analysis. During the respiratory gas analysis, oxygen uptake and carbon dioxide output were measured using a breath-by-breath system with a breathing mask connected to a pre-calibrated computerized gas analyzer.
Calculation of resting substrate oxidation
Time frame: 9 months
We used the respiratory data (oxygen and carbon dioxide) collected during the RMR measurement to calculate resting fat (g/min) and resting carbohydrate oxidation (g/min) using the Frayn equation, as follows: Fat oxidation (g/min) = 1,67 × V̇O2 (L/min) - 1,67 × V̇CO2 (L/min) CHO oxidation (g/min) = 4,55 × V̇CO2 (L/min) - 3,21 × V̇O2 (L/min)
Measurement of substrate oxidation during submaximal exercise
Time frame: 9 months
A few minutes after RMR assessment, participants cycled for 30 minutes at a workload corresponding to 40% of their pre-determined V̇O2max on cycle ergometer (COSMED E 200, Italy) before and after the TRF program. The test commenced with a 3-minute warm-up at 60 W. V̇O2 and V̇CO2 during the test were recorded using an online gas analysis system (Quark Cardio Pulmonary Exercise Testing, COSMED, Rome, Italy). Fat oxidation and CHO oxidation were computed utilizing the equation proposed by Jeukendrup and Wallis.
Food Diary
Time frame: 9 months
All participants completed a 7-day food diary at the commencement of the study, during the third week, and at the end of the sixth week to assess any potential changes in participant dietary habits. An experienced dietician determined the portion size with household units, such as cups, pieces, or plates. In addition, the ingredients of mixed dishes were specified, and product name and standard weights of food items were used to calculate serving sizes. All the results were calculated and analyzed by the same experienced dietician using Nutrition Information System (BEBIS 6.1, Dr. J. Erhardt, Stutgart, Hohenheim, Germany).
Time Restricted Feeding
Time frame: 9 months
The TRF group received detailed nutrition education before the TRF program, and was instructed to follow the 16:8 program for six weeks, limiting their eating window to 8 hours daily (10:00 to 18:00 or alternatively 11:00 to 19:00), during which no calorie restriction was applied. During the 16-hour fasting window, the TRF group was asked to avoid calorie-containing foods and beverages. All participants in both groups were contacted twice a week to monitor dietary compliance in the TRF group and to maintain their existing eating habits in the control group.
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 12 Jul 2024.
- Background: PubMed 32316561Stratton MT, Tinsley GM, Alesi MG, Hester GM, Olmos AA, Serafini PR, Modjeski AS, Mangine GT, King K, Savage SN, Webb AT, VanDusseldorp TA. Four Weeks of Time-Restricted Feeding Combined with Resistance Training Does Not Differentially Influence Measures of Body Composition, Muscle Performance, Resting Energy Expenditure, and Blood Biomarkers. Nutrients. 2020 Apr 17;12(4):1126. doi: 10.3390/nu12041126.
- Background: PubMed 25404320Mattson MP, Allison DB, Fontana L, Harvie M, Longo VD, Malaisse WJ, Mosley M, Notterpek L, Ravussin E, Scheer FA, Seyfried TN, Varady KA, Panda S. Meal frequency and timing in health and disease. Proc Natl Acad Sci U S A. 2014 Nov 25;111(47):16647-53. doi: 10.1073/pnas.1413965111. Epub 2014 Nov 17.
- Background: PubMed 27885007Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
- Background: PubMed 30442801Di Francesco A, Di Germanio C, Bernier M, de Cabo R. A time to fast. Science. 2018 Nov 16;362(6416):770-775. doi: 10.1126/science.aau2095.
- Background: PubMed 32565243Atakan MM, Guzel Y, Bulut S, Kosar SN, McConell GK, Turnagol HH. Six high-intensity interval training sessions over 5 days increases maximal oxygen uptake, endurance capacity, and sub-maximal exercise fat oxidation as much as 6 high-intensity interval training sessions over 2 weeks. J Sport Health Sci. 2021 Jul;10(4):478-487. doi: 10.1016/j.jshs.2020.06.008. Epub 2020 Jun 18.
- Background: PubMed 35859145Atakan MM, Guzel Y, Shrestha N, Kosar SN, Grgic J, Astorino TA, Turnagol HH, Pedisic Z. Effects of high-intensity interval training (HIIT) and sprint interval training (SIT) on fat oxidation during exercise: a systematic review and meta-analysis. Br J Sports Med. 2022 Jul 20:bjsports-2021-105181. doi: 10.1136/bjsports-2021-105181. Online ahead of print.
- Background: PubMed 35858638Atakan MM, Kosar SN, Turnagol HH. Six Sessions of Low-volume High-intensity Interval Exercise Improves Resting Fat Oxidation. Int J Sports Med. 2022 Dec;43(14):1206-1213. doi: 10.1055/a-1905-7985. Epub 2022 Jul 20.
- Background: PubMed 35194047Xie Z, Sun Y, Ye Y, Hu D, Zhang H, He Z, Zhao H, Yang H, Mao Y. Randomized controlled trial for time-restricted eating in healthy volunteers without obesity. Nat Commun. 2022 Feb 22;13(1):1003. doi: 10.1038/s41467-022-28662-5.
- Derived from this study: PubMed 40382896Aktas H, Atakan MM, Aktitiz S, Ergun Z, Kosar SN, Astorino TA, Turnagol HH. Six weeks of time-restricted eating improves basal fat oxidation and body composition but not fat oxidation during exercise in young males. Clin Nutr. 2025 Jul;50:92-103. doi: 10.1016/j.clnu.2025.04.022. Epub 2025 Apr 30.
- 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. This study is not recruiting at the moment.
Muhammed Atakan, PhD study director
Hacettepe University
Hale Aktaş, MSc study chair
Hacettepe University
Hüseyin Turnagöl, Professor principal investigator
Hacettepe 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 Intermittent Fasting: Time Restricted Feeding During 6 Weeks in people with Dietary Exposure, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 12 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 Turkey (Türkiye). 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?
Measurement of body composition (in kg) with Dual-energy X-ray absorptiometry (DXA) (time frame: 9 months). The study lists 7 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 NCT06498102, which also lists 9 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 12 Jul 2024.