UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058429 |
|---|---|
| Receipt number | R000065777 |
| Scientific Title | Effectiveness of the Brief Online Intermittent Fasting Program for Weight Loss: A Randomized Controlled Study |
| Date of disclosure of the study information | 2025/07/11 |
| Last modified on | 2025/07/11 11:00:07 |
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Basic information
Public title
Weight-loss trial of online intermittent fasting program
Acronym
Online IF Study
Scientific Title
Effectiveness of the Brief Online Intermittent Fasting Program for Weight Loss: A Randomized Controlled Study
Scientific Title:Acronym
Online IF Study
Region
| Japan |
Condition
Condition
Overweight and Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in body weight. However, we defined a reduction of 3% or more from baseline body weight as a clinically meaningful change (Minimal Clinically Important Change; MIC). The primary analysis will compare the proportion of participants achieving this MIC threshold between trial arms.
Key secondary outcomes
Body weight, Fat mass, Muscle mass
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
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
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
| 65 | 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 sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services, School of Public Health.
Zip code
606-8501
Address
Konoe-cho, Yoshidakonoe-cho, Sakyo-Ku, Kyoyo
TEL
075-753-2426
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Shimamoto |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
6068501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-2426
Homepage URL
https://yobou.med.kyoto-u.ac.jp/onlineifstudy/
onlineifstudy@yobou.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
HealthTech.Lab Inc.
Name of secondary funder(s)
Ritsuan STC Inc
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学大学院医学研究科（京都府）
（株）株式会社ヘルステック研究所（東京都）
（株）バディトレ（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065777
