UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052655 |
|---|---|
| Receipt number | R000059918 |
| Scientific Title | An examination of the effects of whey on mental health |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2024/10/30 09:24:44 |
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Basic information
Public title
An examination of the effects of protein on mental health
Acronym
Protein on mental health
Scientific Title
An examination of the effects of whey on mental health
Scientific Title:Acronym
The effects of whey on mental health
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study on the effects of whey on mental health in healthy individuals
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Protein powder dissolved in 250 mL of water at a dose of 28 g per day for 4 weeks.
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals aged 18 to 60 who have given consent to participate in this study and own a smartphone.
Key exclusion criteria
Individuals with any illness, allergies to protein or milk, or dysphagia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Kubo |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumi-machi, kiyta-ku, kumamoto
TEL
096-275-2111
kubo@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Kubo |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumi-machi, kiyta-ku, kumamoto
TEL
0962752111
Homepage URL
kubo@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Kumamoto Health Science University
Address
325 Izumi-machi, kiyta-ku, kumamoto
Tel
096-275-2112
kikaku@kumamoto-hsu.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
| 2023 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
26
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 | 08 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059918
