UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054349 |
|---|---|
| Receipt number | R000062083 |
| Scientific Title | The effects of peptide on mood states : A randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2024/05/13 |
| Last modified on | 2026/01/07 13:47:11 |
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Basic information
Public title
The effects of peptide on mood states : A randomized, double-blind, placebo-controlled study
Acronym
The effects of peptide on mood states : A randomized, double-blind, placebo-controlled study
Scientific Title
The effects of peptide on mood states : A randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
The effects of peptide on mood states : A randomized, double-blind, placebo-controlled study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of peptide intake on mood states and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Japanese Adult Short version
Key secondary outcomes
Subjective fatigue (Visual Analog Scale)
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
Intake of powder containing peptide for 12 weeks
Interventions/Control_2
Intake of placebo powder for 12 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects aged 18-64 years
Key exclusion criteria
1) Subjects who have serious illness or medical history such as heart, liver, kidney, respiratory, digestive, etc. or lifestyle-related diseases (diabetes, hyperlipidemia, etc.)
2) Subjects who use foods and drugs associated with mental health.
3) Subjects who have or have history of depression or suspicion of mental disorder.
4) Subjects with chronic fatigue syndrome.
5) Subjects who have severe drug allergies or severe food allergies.
6) Subjects whose BMIs are >=30.
7) Subjects drink alcohol polydipsia (pure alcohol equivalent more than 60 g/day)
8) Subjects who participated in other clinical trials or participated in clinical trials of other drugs or foods within one month before the date of consent acquisition.
9) Subjects who are pregnant or lactating, or who are expected to be pregnant during the study.
10) Subjects who are judged inappropriate to this trial by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakamura |
Organization
Matsumoto City Hospital
Division name
Neurosurgery
Zip code
3901401
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
Japan
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
| 2024 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.31989/ffhd.v15i12.1843
Number of participants that the trial has enrolled
112
Results
The intake of whey-derived peptides resulted in an improvement in mood state.
(Reference)
Effects of Leu-Asp-Gln-Trp-enriched whey protein hydrolysate on mood and fatigue in healthy adults: A randomized, double-blind, placebo-controlled trial.
Results date posted
| 2026 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 14 | 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
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062083
