UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052587 |
|---|---|
| Receipt number | R000060007 |
| Scientific Title | A verification study of the reduction effect of visceral fat: a randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/09/30 17:07:51 |
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Basic information
Public title
A verification study of the reduction effect of visceral fat
Acronym
A verification study of the reduction effect of visceral fat
Scientific Title
A verification study of the reduction effect of visceral fat: a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
A verification study of the reduction effect of visceral fat
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on visceral fat area in healthy individuals
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of abdominal visceral fat area at 12 weeks after consumption (12w)
Key secondary outcomes
1. The amount of change from before consumption of abdominal visceral fat area at 12w
2. The measured values and the amount of changes from before consumption of abdominal total fat area and abdominal subcutaneous fat area at 12w
3. The measured values and the amount of changes from before consumption of abdominal total fat area, abdominal visceral fat area, and abdominal subcutaneous fat area at 8 weeks after consumption (8w)
4. The measured values of body weight, body mass index (BMI), body fat percentage, fat mass, lean body mass, muscle mass, waist circumference, and Calorie and Nutrition Diary (CAND) at 4 weeks after consumption (4w), 8w, and 12w
5. The amount of changes from before consumption of body weight, BMI, body fat percentage, fat mass, lean body mass, muscle mass, waist circumference, and CAND at 4w, 8w, and 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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Tablet containing plant extract
Administration: Chew and take one tablet per day with water as needed
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test food: Tablet not containing plant extract
Administration: Chew and take one tablet per day with water as needed
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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 and women
3. Adults
4. Healthy individuals
5. Individuals whose BMI is 25 kg/m2 or more and less than 30 kg/m2
Key exclusion criteria
1. Individuals who have a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals 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. Individuals who are taking "Foods for Specified Health Uses", "Foods with Functional Claims", or nutritional supplements
5. Individuals who are taking medications (including herbal medicines) and supplements
6. Individuals with allergies to medicines and/or the test food related products
7. Individuals who are heavy smokers (smoking 21 or more cigarettes per day)
8. Individuals who consume excessive alcohol (average daily amount of 40 g or more)
9. Individuals who are shift workers
10. Individuals who have plan for work transfer, long-term business trips, or travel during this study
11. Individuals whose eating habit is irregular
12. Individuals who are on a diet
13. Individuals who are exercising for diet or muscle building
14. Individuals whose exercise habits may change significantly during this study
15. Individuals who are diagnosed with chronic constipation
16. Individuals who are pregnant, lactating, or planning to become pregnant during this study
17. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
18. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
90
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
Morishita Jintan 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
| 2023 | Year | 10 | Month | 23 | 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
100
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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060007
