UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053656 |
|---|---|
| Receipt number | R000061238 |
| Scientific Title | Human studies on the effects of BHB on Sleep. -A randomized, placebo-controlled, double-blind, parallel-group comparison study- |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/08/21 09:51:39 |
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Basic information
Public title
Human studies on the effects of BHB on Sleep.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study-
Acronym
Human studies on the effects of BHB on Sleep.
Scientific Title
Human studies on the effects of BHB on Sleep.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study-
Scientific Title:Acronym
Human studies on the effects of BHB on Sleep.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of BHB-containing food on the sleep quality of healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA-MA
Key secondary outcomes
1) VAS for waking up
2) VAS for fatigue
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
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume the test food at a low dose once a day for 2 weeks.
Interventions/Control_2
Consume the test food at a high dose once a day for 2 weeks.
Interventions/Control_3
Consume placebo food once a day for 2 weeks.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese men and women aged 20 and over but under 65 at informed consent.
2)Subjects who feel temporary fatigue in daily life.
3)Subjects who with a Pittsburgh Sleep Quality Index score of 6 or higher.
4)Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Key exclusion criteria
Subjects who
1)are suffering from or have a history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease
2)at high risk of suffering from idiopathic chronic fatigue or chronic fatigue syndrome based on self-report
3)are presumed to be at high risk of suffering from depression based on CES-D scores or other questionnaires
4)with a history of treatment for sleep disorders or current medical history
5)have been diagnosed with sleep apnea syndrome, or suspected of having it
6)are taking medication or consuming supplements (including functional food products) related to sleep and fatigue recovery
7)have digestive disease or a history of digestive surgery
8)have allergy to the research food
9)are pregnant, lactating, or planning to get pregnant
10)with an infant under one year old in a household
11)sleeps with multiple individuals on a single bedding
12)living with someone requiring long-term care
13)have excessive alcohol intake more than approximately 20g/day of pure alcohol equivalent or habit of drinking more than 4 days a week
14)cannot stop drinking from 2 days before each measurement
15)have an experience of drug dependence or alcohol dependence or current illness
16)smokes more than 20 cigarettes a day or cannot to stop smoking from the time they wake up on the measurement day until the end of the measurement
17)are Shift workers, late-night workers, or with irregular working days and holidays
18)regularly engage in strenuous exercise or work
19)have donated blood or blood components exceeding 200 mL within one month prior to the consent date or 400 mL within three months prior to the consent date
20)plan to participate in other clinical study during study periods or had participated in other clinical study within the last 1 month
21)are judged by the principal investigator to be inappropriate as study subjects for other reasons
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2024 | Year | 02 | Month | 20 | 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
90
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 | 13 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 25 | 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 | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061238
