Nutrition, HealthyTRE-JUDONCT07671443
Early Time-Restricted Eating in Young Judo Athletes
A study testing Early Time-Restricted Eating (e-TRE) in people with Nutrition, Healthy and Muscle Damage, run by University of Manouba at 1 site in Tunisia.
Trial summary
This study investigates the effects of a 5-month early time-restricted eating (e-TRE) intervention on body composition, muscle damage biomarkers, and psychological variables in highly trained young male judo athletes. One hundred participants were randomly assigned to either an e-TRE group or a control group. Read more about this study
- Who is it for?
- Ages 19 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Muscle Damage, Time Restricted Eating
- What is being tested?
- Early Time-Restricted Eating (e-TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2026to 6 Jun 2026
- 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 19 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 19-26 years;
- male judo players; c) with at least 3 years of judo training experience;
- engaged in judo training 5-6 days per week; e) healthy, with no known chronic illnesses or conditions affecting metabolism, mental health, or physical performance;
- willing to adhere to a 16:8 e-TRE protocol for the 5-month study period;
- non-smokers, as smoking may affect anxiety levels and cardiovascular health;
- not using any performance-enhancing drugs or supplements that could interfere with the study's measurements.
Who cannot join
- current musculoskeletal injuries or conditions that could limit participation in training or affect muscle damage biomarkers;
- diagnosed psychiatric disorders or current treatment for anxiety or mood disorders, as these could interfere with psychological assessments;
- use of medications affecting metabolism, muscle recovery, or psychological state (e.g., corticosteroids, antidepressants);
- prior experience with time-restricted eating or intermittent fasting within the past year, as prior adaptation could impact study outcomes;
- dietary restrictions or practices (e.g., vegan or keto diet) that could affect nutrient intake or metabolic markers;
- diagnosed sleep disorders or irregular sleep patterns, as sleep quality could impact both muscle recovery and psychological parameters;
- inability to commit to the structured training program over the study period.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Higher Institute of Sport and Physical Education of Manouba (ISSEP Manouba)
Manouba, Manouba, 2009
About this study
Official title: Effects of a 5-Month Early Time-Restricted Eating Protocol on Body Composition, Muscle Damage Biomarkers, Competitive Anxiety, and Self-Confidence in Highly Trained Young Judo Athletes: A Randomized Controlled Trial
This study investigates the effects of a 5-month early time-restricted eating (e-TRE) intervention on body composition, muscle damage biomarkers, and psychological variables in highly trained young male judo athletes. One hundred participants were randomly assigned to either an e-TRE group or a control group. The e-TRE group followed a 16:8 fasting protocol (07:00-15:00 eating window) while maintaining their usual training program, whereas the control group maintained habitual dietary patterns. Outcomes included changes in body composition (BMI, body fat, skeletal muscle mass), muscle damage biomarkers (CK, LDH, ASAT, ALAT, uric acid, CRP, total bilirubin), and psychological measures (cognitive anxiety, somatic anxiety, and self-confidence assessed using CSAI-2). Measurements were taken at baseline and after the intervention period. The aim of the study is to determine whether e-TRE can improve physiological recovery and psychological readiness in combat sport athletes without negatively affecting performance-related variables.
Read the detailed description
This study was designed to evaluate the effects of a 5-month early time-restricted eating (e-TRE) intervention on physiological and psychological outcomes in highly trained young male judo athletes. The study included 100 participants recruited from competitive judo teams in Tunisia. Participants were randomly assigned to either an e-TRE group or a control group in a 1:1 ratio.
The e-TRE group followed a structured 16:8 time-restricted eating protocol, consuming all daily energy intake within an 8-hour window from 07:00 to 15:00, followed by a 16-hour fasting period. During fasting hours, only non-caloric beverages were permitted. The control group maintained their habitual dietary intake and meal timing without any modifications. Both groups continued their regular judo training program, consisting of 5-6 training sessions per week, including technical drills, sparring (randori), and strength and conditioning exercises.
Anthropometric and biochemical measurements were collected at baseline (T0) and after the 5-month intervention (T1). Psychological assessments were conducted before monthly competitions throughout the study period. Blood samples were collected under standardized resting conditions and analyzed using validated enzymatic and immunoassay techniques.
Participants were required to meet strict inclusion criteria, including age 18-26 years, male sex, at least 3 years of judo training experience, and absence of metabolic, psychiatric, or chronic diseases. Exclusion criteria included use of medications or supplements affecting metabolism, prior experience with intermittent fasting, and conditions that could affect training or biomarker outcomes.
The study was approved by the Ethics Committee of the Higher Institute of Sport and Physical Education of Ksar Said, University of Manouba, Tunisia (approval No. 0171823; organization's unique protocol ID: ISSEP-2026-023) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrollment
Statistical analyses included repeated-measures ANOVA to assess group × time effects, with significance set at p < 0.05. Effect sizes were calculated using partial eta squared (η²).
- Being tested
- Early Time-Restricted Eating (e-TRE)
- Keywords
- Time Restricted Eating, Muscle Damage, Anxiety, Self Confidence, Martial Arts
- Medical subject headings
- Intermittent Fasting, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted Eating (e-TRE)Behavioural
The intervention consisted of a 16:8 early time-restricted eating protocol applied for 5 months. Participants consumed all meals between 07:00 and 15:00, followed by a fasting period from 15:00 to 07:00 the next day. Only non-caloric beverages were allowed during fasting hours. Participants continued their regular judo training (5-6 sessions per week) without modifications. Dietary guidance was provided to support adherence to the eating schedule.
| Study group | Role | What they receive |
|---|---|---|
| Early Time-Restricted Eating (e-TRE) Group | Experimental | Participants in this group followed a 16:8 early time-restricted eating protocol for 5 months. Participants maintained their usual training program throughout the intervention period. Receives: Behavioral: Early Time-Restricted Eating (e-TRE) |
| Control Group | No intervention | Participants in this group maintained their habitual dietary practices. They continued their regular judo training program throughout the 5-month study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competitive Anxiety and Self-Confidence
Competitive anxiety and self-confidence will be assessed using the Competitive State Anxiety Inventory-2 (CSAI-2). This validated questionnaire measures three dimensions of pre-competition psychological state: cognitive anxiety, somatic anxiety, and self-confidence. Scores will be used to evaluate changes in athletes' psychological readiness, emotional response to competition, and perceived self-efficacy.
The CSAI-2 consists of 27 items, divided into three subscales (9 items each). Each item is rated on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("very much so"). Subscale scores are calculated by summing item responses, resulting in a score range of 9 to 36 for each dimension (cognitive anxiety, somatic anxiety, and self-confidence).
Measurements will be taken at baseline (T0) and post-intervention (T1) to determine the effect of early time-restricted eating on competitive anxiety and self-confidence in young judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Creatine kinase (CK)
Creatine kinase (CK) will be used as a marker of muscle damage. Blood samples will be collected to assess changes in CK levels in response to the early time-restricted eating intervention. CK concentrations will be measured in U/L and compared between baseline (T0) and post-intervention (T1, 5 months) in judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)]
Lactate dehydrogenase (LDH)
Lactate dehydrogenase (LDH) will be used as a biomarker of muscle damage. LDH will be measured in U/L to assess changes induced by early time-restricted eating between baseline and post-intervention in judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) will be measured as an indirect marker of muscle damage and metabolic stress. AST levels will be assessed in U/L to evaluate changes from baseline to post-intervention following early time-restricted eating in judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) will be assessed as a biomarker related to muscle stress. ALT levels will be measured in U/L to determine changes following early time-restricted eating between baseline and post-intervention in judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Uric acid
Uric acid will be measured as a metabolic and oxidative stress biomarker. Serum uric acid will be assessed in µmol/L to evaluate changes induced by early time-restricted eating in judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
C-reactive protein (CRP)
C-reactive protein (CRP) will be used as a systemic inflammation biomarker. CRP levels will be measured in mg/L to assess inflammatory response changes following early time-restricted eating between baseline and post-intervention in judo athletes.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Total bilirubin
Total bilirubin will be measured as a marker of oxidative stress and heme metabolism. Serum bilirubin levels will be assessed in µmol/L to evaluate changes induced by early time-restricted eating in judo athletes between baseline and post-intervention.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Secondary outcomes (3)
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). BMI will be used to assess changes in overall body composition status following early time-restricted eating.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Body fat percentage
Body fat percentage will be assessed as an indicator of relative adiposity. Body fat percentage will be expressed as a percentage (%) and measured to evaluate changes following the early time-restricted eating intervention.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Skeletal muscle mass
Skeletal muscle mass will be assessed as an indicator of lean muscle tissue. Skeletal muscle mass will be measured in kilograms (kg) to evaluate changes induced by early time-restricted eating.
Measured: Baseline and 5 months (pre-intervention and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jan 2026
- Primary completion20 Jan 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an early time-restricted eating (e-TRE) group or a control group. The study followed a parallel design, with both groups participating simultaneously over a 5-month intervention period. The e-TRE group followed a 16:8 time-restricted eating protocol, while the control group maintained their habitual dietary practices.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manouba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salento
- Responsible party
- Principal investigator, Maha Gasmi, University of Manouba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671443
- Sponsor's protocol ID
- ISSEP-2026-023
- Acronym
- TRE-JUDO
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 5-Month Early Time-Restricted Eating Protocol on Body Composition, Muscle Damage Biomarkers, Competitive Anxiety, and Self-Confidence in Highly Trained Young Judo Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07671443
- Acronym / sponsor ID
- TRE-JUDO / ISSEP-2026-023
- Keywords
- Time Restricted Eating, Muscle Damage, Anxiety, Self Confidence, Martial Arts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ManoubaUniversity, hospital or other
- Collaborators
- University of Salento
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 26 Jun 2026 (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.
This study investigates the effects of a 5-month early time-restricted eating (e-TRE) intervention on body composition, muscle damage biomarkers, and psychological variables in highly trained young male judo athletes. One hundred participants were randomly assigned to either an e-TRE group or a control group. The e-TRE group followed a 16:8 fasting protocol (07:00-15:00 eating window) while maintaining their usual training program, whereas the control group maintained habitual dietary patterns. Outcomes included changes in body composition (BMI, body fat, skeletal muscle mass), muscle damage biomarkers (CK, LDH, ASAT, ALAT, uric acid, CRP, total bilirubin), and psychological measures (cognitive anxiety, somatic anxiety, and self-confidence assessed using CSAI-2). Measurements were taken at baseline and after the intervention period. The aim of the study is to determine whether e-TRE can improve physiological recovery and psychological readiness in combat sport athletes without negatively affecting performance-related variables.
Detailed description
This study was designed to evaluate the effects of a 5-month early time-restricted eating (e-TRE) intervention on physiological and psychological outcomes in highly trained young male judo athletes. The study included 100 participants recruited from competitive judo teams in Tunisia. Participants were randomly assigned to either an e-TRE group or a control group in a 1:1 ratio.
The e-TRE group followed a structured 16:8 time-restricted eating protocol, consuming all daily energy intake within an 8-hour window from 07:00 to 15:00, followed by a 16-hour fasting period. During fasting hours, only non-caloric beverages were permitted. The control group maintained their habitual dietary intake and meal timing without any modifications. Both groups continued their regular judo training program, consisting of 5-6 training sessions per week, including technical drills, sparring (randori), and strength and conditioning exercises.
Anthropometric and biochemical measurements were collected at baseline (T0) and after the 5-month intervention (T1). Psychological assessments were conducted before monthly competitions throughout the study period. Blood samples were collected under standardized resting conditions and analyzed using validated enzymatic and immunoassay techniques.
Participants were required to meet strict inclusion criteria, including age 18-26 years, male sex, at least 3 years of judo training experience, and absence of metabolic, psychiatric, or chronic diseases. Exclusion criteria included use of medications or supplements affecting metabolism, prior experience with intermittent fasting, and conditions that could affect training or biomarker outcomes.
The study was approved by the Ethics Committee of the Higher Institute of Sport and Physical Education of Ksar Said, University of Manouba, Tunisia (approval No. 0171823; organization's unique protocol ID: ISSEP-2026-023) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrollment
Statistical analyses included repeated-measures ANOVA to assess group × time effects, with significance set at p < 0.05. Effect sizes were calculated using partial eta squared (η²).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an early time-restricted eating (e-TRE) group or a control group. The study followed a parallel design, with both groups participating simultaneously over a 5-month intervention period. The e-TRE group followed a 16:8 time-restricted eating protocol, while the control group maintained their habitual dietary practices.
| Arm | Type | Receives |
|---|---|---|
| Early Time-Restricted Eating (e-TRE) Group | Experimental | Behavioral: Early Time-Restricted Eating (e-TRE)Participants in this group followed a 16:8 early time-restricted eating protocol for 5 months. Participants maintained their usual training program throughout the intervention period. |
| Control Group | No intervention | –Participants in this group maintained their habitual dietary practices. They continued their regular judo training program throughout the 5-month study period. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged 19-26 years;
- male judo players; c) with at least 3 years of judo training experience;
- engaged in judo training 5-6 days per week; e) healthy, with no known chronic illnesses or conditions affecting metabolism, mental health, or physical performance;
- willing to adhere to a 16:8 e-TRE protocol for the 5-month study period;
- non-smokers, as smoking may affect anxiety levels and cardiovascular health;
Key exclusion criteria (7 listed)
- current musculoskeletal injuries or conditions that could limit participation in training or affect muscle damage biomarkers;
- diagnosed psychiatric disorders or current treatment for anxiety or mood disorders, as these could interfere with psychological assessments;
- use of medications affecting metabolism, muscle recovery, or psychological state (e.g., corticosteroids, antidepressants);
- prior experience with time-restricted eating or intermittent fasting within the past year, as prior adaptation could impact study outcomes;
- dietary restrictions or practices (e.g., vegan or keto diet) that could affect nutrient intake or metabolic markers;
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 |
|---|---|---|
| Early Time-Restricted Eating (e-TRE)The intervention consisted of a 16:8 early time-restricted eating protocol applied for 5 months. Participants consumed all meals between 07:00 and 15:00, followed by a fasting period from 15:00 to 07:00 the next day. Only non-caloric beverages were allowed during fasting hours. Participants continued their regular judo training (5-6 sessions per week) without modifications. Dietary guidance was provided to support adherence to the eating schedule. | Behavioural | Early Time-Restricted Eating (e-TRE) Group |
Primary outcome
Competitive Anxiety and Self-Confidence
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Competitive anxiety and self-confidence will be assessed using the Competitive State Anxiety Inventory-2 (CSAI-2). This validated questionnaire measures three dimensions of pre-competition psychological state: cognitive anxiety, somatic anxiety, and self-confidence. Scores will be used to evaluate changes in athletes' psychological readiness, emotional response to competition, and perceived self-efficacy. The CSAI-2 consists of 27 items, divided into three subscales (9 items each). Each item is rated on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("very much so"). Subscale scores are calculated by summing item responses, resulting in a score range of 9 to 36 for each dimension (cognitive anxiety, somatic anxiety, and self-confidence). Measurements will be taken at baseline (T0) and post-intervention (T1) to determine the effect of early time-restricted eating on competitive anxiety and self-confidence in young judo athletes.
Creatine kinase (CK)
Time frame: Baseline and 5 months (pre-intervention and post-intervention)]
Creatine kinase (CK) will be used as a marker of muscle damage. Blood samples will be collected to assess changes in CK levels in response to the early time-restricted eating intervention. CK concentrations will be measured in U/L and compared between baseline (T0) and post-intervention (T1, 5 months) in judo athletes.
Lactate dehydrogenase (LDH)
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Lactate dehydrogenase (LDH) will be used as a biomarker of muscle damage. LDH will be measured in U/L to assess changes induced by early time-restricted eating between baseline and post-intervention in judo athletes.
Aspartate aminotransferase (AST)
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Aspartate aminotransferase (AST) will be measured as an indirect marker of muscle damage and metabolic stress. AST levels will be assessed in U/L to evaluate changes from baseline to post-intervention following early time-restricted eating in judo athletes.
Alanine aminotransferase (ALT)
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Alanine aminotransferase (ALT) will be assessed as a biomarker related to muscle stress. ALT levels will be measured in U/L to determine changes following early time-restricted eating between baseline and post-intervention in judo athletes.
Uric acid
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Uric acid will be measured as a metabolic and oxidative stress biomarker. Serum uric acid will be assessed in µmol/L to evaluate changes induced by early time-restricted eating in judo athletes.
C-reactive protein (CRP)
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
C-reactive protein (CRP) will be used as a systemic inflammation biomarker. CRP levels will be measured in mg/L to assess inflammatory response changes following early time-restricted eating between baseline and post-intervention in judo athletes.
Total bilirubin
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Total bilirubin will be measured as a marker of oxidative stress and heme metabolism. Serum bilirubin levels will be assessed in µmol/L to evaluate changes induced by early time-restricted eating in judo athletes between baseline and post-intervention.
3 secondary outcomes
Body Mass Index (BMI)
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Body fat percentage
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
Skeletal muscle mass
Time frame: Baseline and 5 months (pre-intervention and post-intervention)
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 26 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Eating (e-TRE) in people with Nutrition, Healthy and Muscle Damage, run by University of Manouba at 1 site in Tunisia.
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 6 inclusion and 7 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 26 Jun 2026. 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 Tunisia. 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?
Competitive Anxiety and Self-Confidence (time frame: Baseline and 5 months (pre-intervention and post-intervention)). The study lists 8 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 26 Jun 2026.