UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054231 |
|---|---|
| Receipt number | R000061922 |
| Scientific Title | Effects of consumption of the test food on visceral fat area in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/04/23 |
| Last modified on | 2024/08/19 09:35:01 |
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Basic information
Public title
Effects of consumption of the test food on visceral fat area in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on visceral fat area in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on visceral fat area in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on visceral fat area in healthy Japanese
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 effects of consumption of the test food on visceral fat area and body mass index (BMI) in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of visceral fat area at 12 weeks after consumption (12w) [Low-dose group vs. Placebo group]
2. The measured value of BMI at 12w [Low-dose group vs. Placebo group]
Key secondary outcomes
1. The measured value of visceral fat area at 12w [Normal-dose group vs. Placebo group]
2. The amount and rate of change from screening (before consumption; Scr) of visceral fat area at 12w [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]
3. The measured values of total fat area and subcutaneous fat area at 12w, and the amount and rate of changes of them from Scr [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]
4. The measured value of BMI at 12w [Normal-dose group vs. Placebo group]
5. The amount and rate of change of BMI from Scr to 12w [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]
6. The measured values of body weight, body fat percentage, and waist circumference at 12w, and the amount and rate of changes of them from Scr [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]
7. The measured values of each item in an original questionnaire at 12w [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]
8. The measured values of basal body temperature at PERIOD2~13 and the amount and rate of changes of them from baseline [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]*
9. The measured values of total ketones, acetoacetic acid, and 3-hydroxybutyric acid at 12w, and the amount and rate of changes of them from Scr [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]
*PERIOD1 is defined as the seven days from seven days before the start of the intervention to the day before the start of the intervention. The average value of basal body temperature at PERIOD1 is defined as the baseline.
PERIOD2~13 are defined as periods separated by seven days from the day of the start of the intervention.
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Beverage containing D-beta-hydroxybutyric acid (D-BHB) (BHB 2.9 g/day) [Normal-dose group]
Administration: Take one bottle per day two hours before dinner.
*If you cannot take the test food two hours before dinner, take it as soon as you remember. However, daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test food: Beverage containing D-BHB (BHB 1.5 g/day) [Low-dose group]
Administration: Take one bottle per day two hours before dinner.
*If you cannot take the test food two hours before dinner, take it as soon as you remember. However, daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_3
Duration: 12 weeks
Test food: Beverage not containing D-BHB [Placebo group]
Administration: Take one bottle per day two hours before dinner.
*If you cannot take the test food two hours before dinner, take it as soon as you remember. However, daily dose should be taken within the day and not carried over to the next day.
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 whose BMI is 23 kg/m2 or more and less than 30 kg/m2 at Scr
6. Individuals whose visceral fat area are large at Scr
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who 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. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and/or the test product related products
7. Individuals who exercise at least three times per week
8. Individuals whose lifestyles (particularly dietary habits) are irregular due to working a late-night shift or others
9. Individuals who are on extreme diets, such as "no carbohydrates at all"
10. Individuals who are on a diet
11. Individuals who are pregnant, lactating, or planning to become pregnant during this study
12. 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
13. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
96
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
OSAKA GAS 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
| 2024 | Year | 04 | 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
108
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 | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 11 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061922
