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临床试验/NCT07671443
NCT07671443已完成不适用

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

University of Manouba1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Competitive Anxiety and Self-Confidence

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 26 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Competitive Anxiety and Self-Confidence

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

  • 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))

研究者

发起方
University of Manouba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Gasmi

researcher

University of Manouba

研究点 (1)

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