NCT07671443

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

19 days

First QC Date

June 19, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Time Restricted EatingMuscle DamageAnxietySelf ConfidenceMartial Arts

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline and 5 months (pre-intervention and post-intervention)

Secondary Outcomes (3)

  • Body Mass Index (BMI)

    Baseline and 5 months (pre-intervention and post-intervention)

  • Body fat percentage

    Baseline and 5 months (pre-intervention and post-intervention)

  • Skeletal muscle mass

    Baseline and 5 months (pre-intervention and post-intervention)

Study Arms (2)

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.

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.

Interventions

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.

Early Time-Restricted Eating (e-TRE) Group

Eligibility Criteria

Age19 Years - 26 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is not based on self-reported gender identity. Participants are selected based on biological sex (male) and competitive judo participation.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Higher Institute of Sport and Physical Education of Manouba (ISSEP Manouba)

Manouba, Manouba, 2009, Tunisia

Location

MeSH Terms

Conditions

Intermittent FastingAnxiety Disorders

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 26, 2026

Study Start

January 1, 2026

Primary Completion

January 20, 2026

Study Completion

June 6, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.

Locations