UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056005 |
|---|---|
| Receipt number | R000063997 |
| Scientific Title | A verification study of the anti-obesity effect: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/06/18 17:22:28 |
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Basic information
Public title
A verification study of the anti-obesity effect
Acronym
A verification study of the anti-obesity effect
Scientific Title
A verification study of the anti-obesity effect: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A verification study of the anti-obesity effect
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the anti-obesity effect of consumption of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of the visceral fat area at 12 weeks after intervention (12w)
Key secondary outcomes
1. The measured values of the total fat area and the subcutaneous fat area at 12w
2. The measured values of the defecation frequency, the numbers of defecation days, and the amount of defecation in period 2~13*
*Period 2~13: Periods separated by 7 days from the start of intervention
3. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 2~13 compared to period 1*
*Period 1: 7 days prior to screening (before intervention; Scr)
4. The score of the Constipation Assessment Scale (CAS) at 12w
5. Individuals whose responses to each item in the CAS Middle Term version (CAS-MT) improved by one or more scales at 12w compared to Scr
6. The measured values of the occupancy rate of bacteria in the stool and the alpha diversity index at 12w
7. The measured values of the body weight, body fat percentage, and waist circumference at 12w
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
The test food
Interventions/Control_2
Duration: 12 weeks
Placebo
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who defecate three to five times in Period 1
6. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2
7. Individuals who are classified as "Hidden Obese" or "Obese" in the body composition measurement at Scr
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking or using medications (including herbal medicines) and supplements
6. are allergic to medicines and foods related to the test product
7. are pregnant, lactating, or planning to become pregnant during this study
8. have chronic constipation or diarrhea
9. have had diarrhea for at least 2 weeks prior to agreeing to participate
10. meet the diagnostic criteria for irritable bowel syndrome (IBS) or have already been diagnosed with IBS
11. have other diseases that may significantly affect bowel movement
12. usually take foods containing rich in lactic acid bacteria, or health foods or medicines fortified with lactic acid bacteria
13. usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber)
14. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
15. are judged as ineligible to participate in this study by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ICHIMARU PHARCOS Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 16 | 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
34
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063997
