UMIN-CTR Clinical Trial

Basic information
Public title	Effects of peptide ingestion on sleep: a randomized, double-blind, placebo-controlled, parallel-group study
Acronym	Effects of peptide ingestion on sleep
Scientific Title	Effects of peptide ingestion on sleep: a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym	Effects of peptide ingestion on sleep
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of peptide on sleep by comparing them to placebo
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of OSA Sleep Inventory MA version after 2 weeks of intake
Key secondary outcomes	Evaluation of the following items after 2 weeks of intake 1) questionnaires about stress and quality of life 2) salivary markers

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the peptide foods for 2 weeks
Interventions/Control_2	Intake of the placebo for 2 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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females aged 30-64 years old 2) Subjects who have received a full explanation of the study, understand its contents, and have given their written consent to participate in the study
Key exclusion criteria	1) Subjects who are undergoing medical treatment or diagnosed as needing medical treatment 2) Subjects who are pregnant, lactation, or planning to become pregnant during this study 3) Subjects who have history of serious disorders (Cerebrovascular disease, Cardiac disorder, Hepatic disorders, Gastrointestinal disorder, Endocrine-related disorder, etc.) 4) Subjects who have or have a history of sleep disorders such as insomnia or sleep apnea syndrome (SAS) 5) Subjects with medication allergies, food allergies, or a serious history of such allergies 6) Subjects who have or have a history of drug addiction or alcoholism 7) Subjects who are judged by the principal investigator to have an irregular lifestyle 8) Subjects who regularly use medicines, supplements, etc. 9) Subjects who urinate more than 3 times during the night 10) Extremely heavy drinkers (more than 60g/day of alcohol) 11) Subjects who have participated in other drug or food trials within the past month, or are willing to participate during this study 12) Subjects who are judged as ineligible to participate in this study by the principal investigator
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hatsuko Middle name Last name Abo
Organization	KAYABA-CHO MENTAL HEALTH CARE CLINIC
Division name	director
Zip code	103-0025
Address	Nihonbashi Kayabacho2-8-10 Chuo-ku, Tokyo, Japan
TEL	03-5643-9855
Email	phatsuko.ab@gmail.com

Public contact
Name of contact person	1st name Shigeru Middle name Last name Imai
Organization	Leverage Brain Inc.
Division name	Clinical Trial Department
Zip code	105-0004
Address	Shinbashi2-16-1 Minato-ku, Tokyo, Japan
TEL	080-7290-0404
Homepage URL
Email	imai@levbrain.com

Sponsor
Institute	Leverage Brain Inc.
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	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.com

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	茅場町こころのケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 24 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	2021 Year 02 Month 18 Day
Date of IRB	2021 Year 02 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 24 Day
Last follow-up date	2021 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	2021 Year 02 Month 22 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049561