UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062514 |
|---|---|
| Receipt number | R000071546 |
| Scientific Title | Anti-Obesity and Bowel Movement Improvement Effects of Food Component Intake: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 16:26:17 |
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Basic information
Public title
Anti-Obesity and Bowel Movement Improvement Effects of Food Component Intake: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Acronym
A Study on Anti-Obesity and Bowel Movement Effects of a Food Component
Scientific Title
Anti-Obesity and Bowel Movement Improvement Effects of Food Component Intake: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Scientific Title:Acronym
A Study on Anti-Obesity and Bowel Movement Effects of a Food Component
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the anti-obesity and bowel movement improvement effects of a food component intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
1. Subcutaneous fat area
2. Total fat area
3. Waist and hip circumference
4. Thigh circumference and upper arm circumferences
5. Body composition (body fat percentage, body fat mass, muscle mass)
6. Body Weight
7. Body Mass Index
8. Bowel movement frequency
9. Stool consistency
10. Visual Analogue Scale(fatigue sensation)
11. POMS2 (Full Items Version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking the test food for 12 consecutive weeks.
Interventions/Control_2
Taking the control food for 12 consecutive weeks.
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
1. Healthy men and women aged 20 years or older and under 65 years at the time of obtaining consent
2. Individuals with a BMI of 25 or more and less than 30 at the time of screening
3. Individuals who have received sufficient explanation of the purpose and content of this study, have the capacity to consent, have fully understood it, voluntarily wish to participate, and have provided written informed consent to participate in this study
Key exclusion criteria
Individuals who/with:
1. Using medications affecting obesity or bowel movements
2. Cannot discontinue FOSHU, Foods with Function Claims, or supplements affecting obesity or bowel movements
3. Have chronic diseases requiring regular medication
4. Suffering from serious liver, cardiovascular, respiratory, endocrine, metabolic disorders, or food allergies
5. History of drug or alcohol dependence
6. Metal implants in CT scan area
7. Claustrophobia interfering with CT scanning
8. Cardiac pacemakers or implantable defibrillators
9. Diagnosed with familial hyperlipidemia
10. Food allergies
11. Heavy smoking (>=21 cigarettes/day)
12. History of gastrointestinal diseases or surgery affecting digestion/absorption (excluding appendicitis)
13. Habitual alcohol consumption >20g/day on >=4 days/week
14. Extremely irregular eating habits or shift/night workers
15. Blood donation of 200mL within 1 month or >400mL/component donation within 3 months
16. Participating in or intending to join other clinical studies
17. Pregnant, lactating, or planning pregnancy during study
18. Judged inappropriate by principal investigato
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Yaizu Suisankagaku Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 07 | 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
| 2026 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071546
