UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059063 |
|---|---|
| Receipt number | R000067559 |
| Scientific Title | ime-Restricted Eating Without Exercise Enhances Anaerobic Power and Reduces Body Weight: A Randomized Crossover Trial in Untrained Adults |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/11 19:46:09 |
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Basic information
Public title
Effects of Time-Restricted Eating on Body Weight and Physical Performance in Young Adults
Acronym
Time-Restricted Eating - Anaerobic Power and Weight
Scientific Title
ime-Restricted Eating Without Exercise Enhances Anaerobic Power and Reduces Body Weight: A Randomized Crossover Trial in Untrained Adults
Scientific Title:Acronym
TRE-APW Trial
Region
| Japan |
Condition
Condition
Not applicable (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the effects of two types of time-restricted eating (TRE) - an early window (08:00-14:00) and a midday window (12:00-18:00) - on body weight, aerobic endurance, and anaerobic power in healthy young adults. Without any exercise intervention, this trial adopts a randomized crossover design to determine which eating window is more effective for improving metabolic and physical performance outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in body weight (measured at baseline, 4 weeks, and 10 weeks after intervention initiation)
Key secondary outcomes
AAerobic endurance: time to exhaustion on a cycle ergometer at a constant workload of 150 W for men and 90 W for women, defined as the point when cadence could no longer be maintained at >=60 rpm for 10 consecutive seconds (measured at baseline, 4 weeks, and 10 weeks after intervention initiation); Anaerobic power: peak power output during three 10-second maximal cycling sprints on a cycle ergometer (measured at baseline, 4 weeks, and 10 weeks after intervention initiation)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Early Time-Restricted Eating (eTRE): Participants were instructed to consume all meals within a 6-hour window between 08:00 and 14:00 each day, and to refrain from any caloric intake outside this window. The intervention lasted for 4 weeks, and no exercise intervention was implemented. Primary outcomes included changes in body weight, aerobic endurance, and anaerobic power.
Interventions/Control_2
Delayed Time-Restricted Eating (dTRE): Participants were instructed to consume all meals within a 6-hour window from 12:00 to 18:00 each day, and to refrain from any caloric intake outside this window. The intervention lasted for 4 weeks, with no exercise intervention. Primary outcomes included changes in body weight, aerobic endurance, and anaerobic power.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 26 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Healthy university students aged 20 to 26
- Body mass index (BMI) < 30 (non-obese)
- No history of cardiovascular, metabolic, or musculoskeletal disorders
- No current smoking or habitual alcohol consumption
- Not participating in any structured exercise program during the study period
- Willingness and ability to adhere to the assigned time-restricted eating schedules and study protocols
- Provided written informed consent prior to participation
Key exclusion criteria
- Individuals with a diagnosed history of cardiovascular, metabolic, or musculoskeletal disorders
- Individuals who currently smoke or consume alcohol on a regular basis
- Individuals who are actively participating in a structured exercise program during the study period (e.g., sports club activities, personal training)
- Individuals who are unable or unwilling to comply with the time-restricted eating schedule or dietary control
- Individuals engaged in shift work or those with irregular sleep-wake cycles
- Individuals participating in other clinical trials during the study period
- Individuals who are unable to provide written informed consent
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Zifu |
| Middle name | |
| Last name | Yu |
Organization
Graduate School of Humanities and Social Sciences, Hiroshima University
Division name
Department of Educational Sciences
Zip code
739-0041
Address
C201, Haruha Lane, 7247-1 Jike, Saijo-cho, Higashihiroshima-shi, Hiroshima 739-0041, Japan
TEL
080-9364-6721
d211386@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Zifu |
| Middle name | |
| Last name | Yu |
Organization
Graduate School of Humanities and Social Sciences, Hiroshima University
Division name
Department of Educational Sciences
Zip code
739-0041
Address
C201, Haruha Lane, 7247-1 Jike, Saijo-cho, Higashihiroshima-shi, Hiroshima 739-0041, Japan
TEL
080-9364-6721
Homepage URL
d211386@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Yu Zifu
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hiroshima University
Address
1-1-1 Kagamiyama, Higashihiroshima City, Hiroshima Prefecture 739-8511, Japan
Tel
082-424-6705
ed-ken-zai@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学運動生理学実験室
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 28 healthy university students (12 males and 16 females, aged 18-26 years) participated in this study. All participants had a body mass index (BMI) below 30 and no history of cardiovascular, metabolic, or musculoskeletal disorders. None of the participants were engaged in any structured exercise program during the study period.
Participant flow
In total, 39 individuals were initially screened for eligibility. After the interview and screening process, 28 participants (12 males and 16 females) were enrolled in the study. All participants completed both intervention phases (eTRE and dTRE), and there were no dropouts. Data from all 28 participants were included in the final analysis.
Adverse events
no
Outcome measures
The study included the following three primary outcome measures:
Body weight: Measured in the afternoon (between 15:00 and 17:00) at each assessment point (baseline, week 4, and week 10), under standardized fasting conditions.
Aerobic endurance (time to exhaustion): Assessed using a cycle ergometer at constant load (150 W for men, 90 W for women). The test ended when cadence fell below 60 rpm for more than 10 consecutive seconds.
Anaerobic power (peak power output): Participants performed three 10-second all-out sprints on a cycle ergometer, and the highest peak power output (in watts) was recorded.
All outcomes were assessed at baseline, after 4 weeks, and after 10 weeks of intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067559
