UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043407 |
|---|---|
| Receipt number | 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 | 2021/07/14 17:28:21 |
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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
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
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049561
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
