UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044948 |
|---|---|
| Receipt number | R000051348 |
| Scientific Title | Evaluation of anti-fatigue effect of black soybean seed coat beverage |
| Date of disclosure of the study information | 2021/07/26 |
| Last modified on | 2025/01/16 11:09:19 |
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Basic information
Public title
Evaluation of anti-fatigue effect of black soybean seed coat beverage
Acronym
Evaluation of anti-fatigue effect of black soybean seed coat beverage
Scientific Title
Evaluation of anti-fatigue effect of black soybean seed coat beverage
Scientific Title:Acronym
Evaluation of anti-fatigue effect of black soybean seed coat beverage
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-fatigue effect of black soybean seed coat beverage in human
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale
Key secondary outcomes
POMS2 Japanese version
Stress Arousal Check List Japanese version
Urinalysis
Body measuring/Physical examination
Saliva alpha-amylase activity
Peripheral blood flow
Questionnaire
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
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test material: black soybean seed coat beverage
Duration: 6 weeks
Dose: 200mL/day (divide into two portions of 100mL each)
Interventions/Control_2
Control material: placebo beverage
Duration: 6 weeks
Dose: 200mL/day (divide into two portions of 100mL each)
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1) Healthy females aged between the ages of 20 and 40.
2) Subjects who are capable of understanding the study, and those who can give written informed consents.
Key exclusion criteria
1) Subjects who are allergic to products related to the test material (e.g. soybean) of this study.
2) Subjects who take drugs, quasi-drugs, dietary supplements, health foods or something other which possibly have effects on this study.
3) Patients with organic diseases which apparently induce fatigue.
4) Subjects who are addicted to alcohol or has an extremely irregular dietary habit.
5) Subjects who are pregnant or breastfeeding, or desires to get pregnant during the study period.
6) Subjects who are judged unsuitable for this study by principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Oki |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
tomooki@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Oki |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
Homepage URL
tomooki@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Foods Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nakamura Gakuen University Ethics Review Committee
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
Tel
092-851-5579
kks@nakamura-u.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
中村学園大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/archive/search?jo=ai6yrtyb&vo=51&issue=7&UserID=113.34.202.92
Number of participants that the trial has enrolled
24
Results
The elevation of mood state score on total mood disturbance was significantly improved after six weeks of consuming the test beverage compared to the placebo. The scores of anger-hostility and depression-dejection were significantly lower compared to the placebo. In addition, feeling of vitality score in the test beverage group was higher than that in the placebo group.
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051348
