UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056150 |
|---|---|
| Receipt number | R000060828 |
| Scientific Title | Effects of time-restricted eating on physique and metabolism in healthy young people |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/13 21:55:35 |
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Basic information
Public title
Effects of time-restricted eating on physique and metabolism in healthy young people
Acronym
Effects of time-restricted eating on physique and metabolism in healthy young people
Scientific Title
Effects of time-restricted eating on physique and metabolism in healthy young people
Scientific Title:Acronym
Effects of time-restricted eating on physique and metabolism in healthy young people
Region
| Japan |
Condition
Condition
Healthy men and women aged 18 to 39 who are obese with a BMI of more than 25 kg/m2 or have a high body fat percentage.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effects of mealtime restriction on body composition and metabolic markers without dietary modification by dividing subjects into three groups: an 10-hour time-restricted diet group, a 12-hour time-restricted diet group, and a no-time-restricted diet control group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Body composition, metabolic markers.
Key secondary outcomes
Dietary habits survey, simple self-administered dietary questionnaire (BDHQ), meal record (with guideline/photography method), physical activity survey (IPAQ-SF), 3-dimensional sleep scale, blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The 10-hour group will have 10 hours of eating time per day and 14 hours of fasting time on the same day. This will continue for 12 weeks. Before and after this 12-week intervention, physical measurements, blood biochemistry tests, blood pressure, eating habits survey, BDHQ, food records (using both standard and photographic methods), 3DSS, and IPAQ-SF surveys will be conducted.
Interventions/Control_2
The 12-hour group will have 12 hours of eating time per day and 12 hours of fasting time on the same day. This will continue for 12 weeks. Before and after this 12-week intervention, physical measurements, blood biochemistry tests, blood pressure, eating habits survey, BDHQ, food records (using both standard and photographic methods), 3DSS, and IPAQ-SF surveys will be conducted.
Interventions/Control_3
The control group will spend a 12-week intervention period without changing their living time. Before and after this intervention, physical measurements, blood biochemistry tests, blood pressure, eating habits survey, BDHQ, dietary records (using both standard and photographic methods), 3DSS, and IPAQ-SF surveys will be conducted.
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age is 18~39 years old. (2) There is no disease under treatment and there is no hindrance to eating habits or exercise, (3) Obesity with a BMI of 25 kg/m2 or more, and a high body fat percentage, (4) There is no exercise habit of exercising for at least 30 minutes at a time, at least twice a week for more than one year, and (5) Eating time is 14 hours or more.
Key exclusion criteria
Excludes individuals with medical conditions that require dietary or exercise restrictions.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | shino |
| Middle name | |
| Last name | ujike |
Organization
Tenshi colleg
Division name
School of Nursing and Nutrition
Zip code
065-0013
Address
Higashi-Ku,Kita-13 Higashi-3,Sapporo,Japan
TEL
011-741-1051
ujike@sapporo-hokeniryou-u.ac.jp
Public contact
Name of contact person
| 1st name | shino |
| Middle name | |
| Last name | ujike |
Organization
Tenshi colleg
Division name
School of Nursing and Nutrition
Zip code
065-0013
Address
Higashi-Ku,Kita-13 Higashi-3,Sapporo,Japan
TEL
011-741-1051
Homepage URL
ujike@sapporo-hokeniryou-u.ac.jp
Sponsor or person
Institute
Tenshi colleg
Institute
Department
Personal name
Shino ujike
Funding Source
Organization
none
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
Tenshi colleg
Address
Higashi-Ku,Kita-13 Higashi-3,Sapporo,Japan
Tel
011-741-1051
kenkyurinri@tenshi.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
天使大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 13 | 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
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060828
