Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059063) titled 'Effects of Time-Restricted Eating on Body Weight and Physical Performance in Young Adults' on Sept. 12.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Not applicable (healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 28
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067559
Disclaimer: Curated by HT Syndication.