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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043407
Receipt No. R000049561
Scientific Title Effects of peptide ingestion on sleep: a randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2021/02/24
Last modified on 2021/02/22

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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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 18 Day
Date of IRB
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 02 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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