UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047487 |
|---|---|
| Receipt number | R000054131 |
| Scientific Title | The effects of peptide on mental health in adults: A randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2022/04/15 |
| Last modified on | 2022/10/18 13:27:05 |
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Basic information
Public title
The effects of peptide on mental health in adults: A randomized, double-blind, placebo-controlled study
Acronym
The effects of peptide on mental health in adults: A randomized, double-blind, placebo-controlled study
Scientific Title
The effects of peptide on mental health in adults: A randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
The effects of peptide on mental health in adults: A randomized, double-blind, placebo-controlled study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of peptide on mental health.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of POMS2
Key secondary outcomes
1) VAS (fatigue, stress, sleep)
2) STAI
3) Stress markers in saliva
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food for 4 weeks.
Interventions/Control_2
Ingestion of the placebo food for 4 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20-64 years old.
2) Subjects with mental health complaints.
Key exclusion criteria
1) Subjects who use supplements, functional foods, or drugs associated with mental health.
2) Subjects with a history of and/or current mental illness or suspicion of mental illness.
3) Subjects who are undergoing medical treatment or have a previous medical history of serious diseases.
4) Subjects who have excessive alcoholic drinks (more than 60 g/day of alcohol).
5) Subjects who have severe drug allergy or severe food allergy, and/or a previous medical history of such allergies.
6) Subjects who participated in other clinical studies within 1 month before giving informed consent to participate in this study, or are planning to participate in other studies during this study.
7) Subjects who are pregnant or lactating, or who are expected to be pregnant during the study.
8) Subjects who are judged as ineligible to participate in this study by the principal investigator based on their background, physical findings, and so on.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakamura |
Organization
Matsumoto City Hospital
Division name
Hospital Director
Zip code
390-1401
Address
4417-180 Hata, Matsumoto, Nagano, Japan
TEL
0263-92-3027
hospi@city.matsumoto.lg.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Furuhata |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
info@m-health-lab.jp
Sponsor or person
Institute
Matsumoto City Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Research Ethics Committee of Matsumoto City Hospital
Address
4417-180 Hata, Matsumoto, Nagano, Japan
Tel
0263-92-3027
hospi@city.matsumoto.lg.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
| 2022 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054131
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| Registered date | File name |
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