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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Early Time-Restricted Eating (e-TRE)
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

Other trials in Tunisia

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 groups in NCT07671443
Study groupRoleWhat they receive
Early Time-Restricted Eating (e-TRE) GroupExperimentalParticipants 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 GroupNo interventionParticipants 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.

  1. 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)

  2. 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)]

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)
  1. 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)

  2. 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)

  3. 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.

  1. First posted26 Jun 2026
  2. Study start1 Jan 2026
  3. Primary completion20 Jan 2026
  4. Study completion6 Jun 2026

Resources

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)
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.

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.

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