Tokyo, July 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058429) titled 'Weight-loss trial of online intermittent fasting program' on July 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Kyoto University

Condition: Condition - Overweight and Obesity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effectiveness of the Brief Online Intermittent Fasting Program for weight-loss in a randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The Brief Online IF Program

A. Initial Fasting Guidance Session (Single Session) One-time online instruction prior to intervention initiation covers IF protocols (e.g., 16:8 method), safety precautions, and self-monitoring

B. Participant-Led Fasting Implementation Self-administered intermittent fasting (e.g., 16-hour fasting/8-hour eating window)

C. Weekly Support Messages Automated reminders/encouragement to maintain protocol adherence Behavioral prompts based on cognitive restructuring techniques

D. Minimalist Bodyweight Exercises (3x/Week) Standardized 10-15 minute home-based routines (e.g., squats, push-ups, planks) Optional video demonstrations with progressive difficulty levels

E. Monthly Dietitian Follow-Up 15-minute telehealth consultations for troubleshooting Standardized assessment of adverse events and protocol deviations Interventions/Control_2 - The active control group received matched attention through weekly lifestyle messages, controlling for nonspecific intervention effects while withholding fasting-specific components

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Generally healthy adults who aged 20 to 65 whose BMI 23 or more. can take regular 1 day off. can communicate in Japanese. have access to the Internet and can use mobile app during the study. can visit Kyoto university at baseline and 12th week for the outcome measurement. can have blood drawn and fast before at the measurements. understand the study content and are willing to join the program. Key exclusion criteria - BMI 35 or more. have history of heart disease, kidney disease, and other major medical conditions. medication of anti-diabetics. smoker or heavy drinker - average 4 or more drinks per day, or 14 or more drinks per week. night-shift worker. possibility of moving, job change, travel abroad and other substantial change of living condition. lactating, pregnant, or plan to be pregnant during the study. men with fat percentage of 10% or less, or women with fat percentage of 20% or less. professional or amateur athletes. commitment to athletic or physical training of 12 hours or more per week. other reasons recognized as inappropriate by the researcher. Target Size - 72

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 01 Day Date of IRB - 2025 Year 07 Month 07 Day Anticipated trial start date - 2025 Year 07 Month 15 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065777

Disclaimer: Curated by HT Syndication.