UMIN-CTR Clinical Trial

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
Email	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
Email	info@m-health-lab.jp

Sponsor
Institute	Matsumoto City Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054131