UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056743 |
|---|---|
| Receipt number | R000064847 |
| Scientific Title | The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental fatigue in healthy adult: a randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2025/01/17 15:05:59 |
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Basic information
Public title
The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental fatigue in healthy adult
Acronym
The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental health
Scientific Title
The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental fatigue in healthy adult: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental health
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of beta-hydroxybutyrate (D-BHB) intake on physical and mental health in healthy adult
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue visual analog scale
The Depression Anxiety Stress Scales-21
Profile of Mood States 2
OSA sleep inventory MA version
Key secondary outcomes
Chalder Fatigue Scale
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To dissolve D-BHB-containing protein (D-BHB 2 g/day) in 200 ml of water and intake it for 4 weeks (28 days)
Interventions/Control_2
To dissolve the placebo protein not containing D-BHB in 200 ml of water and intake it for 4 weeks (28 days)
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) persons who is generally judged as healthy
(2) Persons who can give voluntary written consent to participate in the present trial
(3) Persons who are aware of their physical and mental fatigue and stress
Key exclusion criteria
(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) persons who have been treated their illness or prevention in a clinic at their informed consent
(5) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) persons with the medical histories of alcoholism or drug dependence
(7) persons who might be developed allergic reaction to foods
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) persons who will not be judged suitable to the participants by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kouichirou |
| Middle name | |
| Last name | Ohnuki |
Organization
User Life Science Co.,Ltd.
Division name
The research and development part
Zip code
820-0115
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
TEL
0948823123
ohnuki.rinp@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ohnuki |
Organization
User Life Science Co.,Ltd.
Division name
The research and development part
Zip code
820-0115
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
TEL
0948-82-3123
Homepage URL
userlifescience@gmail.com
Sponsor or person
Institute
User Life Science Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Genten Honten Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Humanity-Oriented Science and Engineering, Kindai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University, Faculty of humanity-oriented science and engineering, Ethics Committee
Address
11-6,Kayanomori,Iiduka-shi,Fukuoka,Japan
Tel
0948-22-5655
ohnuki@fuk.kindai.ac.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
| 2026 | Year | 02 | Month | 28 | 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
37
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 | 20 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064847
