UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061861 |
|---|---|
| Receipt number | R000070782 |
| Scientific Title | A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/10 13:59:34 |
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Basic information
Public title
A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study
Acronym
A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study
Scientific Title
A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study
Scientific Title:Acronym
A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food
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 blood levels of beta-hydroxybutyric acid, insulin, and glucose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The incremental area under the curve (IAUC) of 3-hydroxybutyric acid
Key secondary outcomes
1. The total areas under curve (TAUC) and the maximum blood concentration (Cmax) of 3-hydroxybutyric acid, and the measured values of 3-hydroxybutyric acid at each assessment point
2. IAUC, TAUC, and Cmax of glucose, and the measured values of glucose at each assessment point
3. IAUC, TAUC, and Cmax of insulin, and the measured values of insulin at each assessment point
4. The measured values of subjective satiety at each assessment point
5. Individuals who experienced adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
<Duration>
Single ingestion
<Test product>
Test1: Low carb bar containing medium chain fatty acid
Test2: Isocaloric low carb bar
*Test 1 followed by Test 2.
*The washout period is one week.
Interventions/Control_2
<Duration>
Single ingestion
<Test product>
Test1: Isocaloric low carb bar
Test2: Low carb bar containing medium chain fatty acid
*Test 1 followed by Test 2.
*The washout period is one week.
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 whose BMI is 18.0 or more and less than 25.0
Key exclusion criteria
1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
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 consume Foods for Specified Health Uses or Foods with Functional Claims
5. Individuals who are taking or using medicines (including herbal medicines) or supplements
6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to wheat, milk, soybeans, almonds, walnuts, oranges, bananas, apples, or cashew nuts.
7. Individuals who are pregnant, lactating, or planning pregnancy during this study
8. Individuals who are on ketogenic diet
9. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
10
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
UHA Mikakuto Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
UHA Mikakuto Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
COMP Inc.
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
| 2026 | Year | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 21 | 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 | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070782
