UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056883 |
|---|---|
| Receipt number | R000063891 |
| Scientific Title | Study on the Effects of Test Food Intake on Visceral Fat |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/03/24 19:43:48 |
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Basic information
Public title
Study on the Effects of Test Food Intake on Visceral Fat
Acronym
Study on the Effects of Test Food Intake on Visceral Fat
Scientific Title
Study on the Effects of Test Food Intake on Visceral Fat
Scientific Title:Acronym
Study on the Effects of Test Food Intake on Visceral Fat
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of test food intake on visceral fat. The study will also examine changes in AGEs, skin, sleep quality, and hair quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area measured by X-ray computed tomography (CT).
Key secondary outcomes
Waist circumference, Body fat percentage, Total cholesterol (T-cho), Glucose (GLU), Hemoglobin A1c (HbA1c), Adiponectin levels, Total abdominal fat area (X-ray CT), Subcutaneous abdominal fat area (X-ray CT), Stratum corneum moisture content, Skin viscoelasticity, Transepidermal water loss, Advanced glycation end-products (AGEs), Pittsburgh Sleep Quality Index (PSQI)
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
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral administration of the test food (1 sachet, twice daily) for 16 weeks
Interventions/Control_2
Oral administration of the placebo food (1 sachet, twice daily) for 16 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 to below 60 years at the time of consent acquisition.
2. Individuals with a BMI between 23.0 and less than 30.0 kg/m2 at the time of pre-examination.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals regularly using Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including supplements) more than three times a week that claim to reduce visceral fat or body fat, and cannot discontinue their use from the time of consent.
2. Individuals unable to discontinue intake of FOSHU, Foods with Function Claims, or health supplements (including supplements) that claim to reduce visceral fat or body fat from the time of consent (those who intake these less than twice a week and can discontinue may participate).
3. Individuals engaged in dietary restrictions or diets aimed at weight loss (defined as weight loss through exercise or by reducing food intake).
4. Individuals with scars or marks at the skin measurement sites.
5. Individuals with long nails or who wear three-dimensional nail art.
6. Individuals with non-removable metal objects (such as bolts or metal plates) in the CT imaging area.
7. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
8. Individuals with extremely irregular life or eating habits, such as shift workers or night workers.
9. Individuals with excessive alcohol intake.
10. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
11. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
12. Individuals with allergies to medications and/or food.
13. Individuals who donated 200 mL of their blood or blood components within the last month.
14. Individuals who donated 400 mL of his blood within the last 3 months.
15. Individuals who donated 400 mL of her blood within the last 4 months.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nikkenkyo Service 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2025 | Year | 01 | Month | 31 | 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
60
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 | 12 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
16. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
17. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
18. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063891
