UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059551 |
|---|---|
| Receipt number | R000068082 |
| Scientific Title | A Randomized, Placebo-Controlled Crossover Study on the Effects of Roasted Hassho-mame (Mucuna Bean) Tea Consumption on Psychological State, Fatigue, and Sleep Quality |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/27 14:37:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Roasted Hassho-mame (Mucuna beans) Tea Consumption on Psychological State, Fatigue, and Sleep Quality
Acronym
Health Effects of Roasted Hassho-mame (Mucuna beans) Tea
Scientific Title
A Randomized, Placebo-Controlled Crossover Study on the Effects of Roasted Hassho-mame (Mucuna Bean) Tea Consumption on Psychological State, Fatigue, and Sleep Quality
Scientific Title:Acronym
A Randomized, Placebo-Controlled Crossover Study on the Health Effects of Roasted Hassho-mame Tea
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of roasted Hassyo (Mucuna) bean consumption on mood, fatigue, stress, and sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States 2 (POMS2).
Key secondary outcomes
Fatigue, stress, and sleep quality.
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test beverage: 2.3 g of roasted Mucuna beans and 1.0 g of black soybeans infused in 500 mL of water per day for two weeks.
Interventions/Control_2
Placebo beverage: 1.0 g of black soybeans infused in 500 mL of water per day for two weeks.
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
Healthy adult men and women
Key exclusion criteria
Individuals receiving any medication prescribed by a physician; those who are pregnant or breastfeeding; and those with allergies to soybeans or other legumes.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Kono |
Organization
Osaka kawasaki rehabilitation university
Division name
Department of Rehabilitation
Zip code
597-0104
Address
Mizuma 158, Kaizuka, Osaka
TEL
0724466767
konor@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Kono |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
Mizuma 158, Kaizuka City, Osaka
TEL
0724466767
Homepage URL
konor@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Kishu-Hosokawa
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
Ethics committee of Osaka Kawasaki Rehabilitation University
Address
Mizuma 158, Kaizuka City, Osaka
Tel
0724466700
rinri@kawasakigakuen.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
| 2025 | Year | 10 | Month | 30 | 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
| 2025 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068082
