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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042438
Receipt No. R000048447
Scientific Title Exploratory study of activity after intake of foods containing SNR14 in healthy volunteers
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/13

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Basic information
Public title Exploratory study of activity after intake of foods containing SNR14 in healthy volunteers
Acronym Exploratory study of activity after intake of foods containing SNR14 in healthy volunteers
Scientific Title Exploratory study of activity after intake of foods containing SNR14 in healthy volunteers
Scientific Title:Acronym Exploratory study of activity after intake of foods containing SNR14 in healthy volunteers
Region
Japan

Condition
Condition Healthy Volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the changes in activity after intake of foods containing SNR14 and feasibility of tests using wristwatch-type devices.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of activity (physical activity intensity (METs), number of steps, speed, time, location information (GPS))
Key secondary outcomes (Exploratory measurement item)
Heart rate, sleep quality (sleep score, sleep time, sleep interruption time), body composition (weight, body water content, muscle mass, body fat mass, body fat percentage, basal metabolic rate, visceral fat level), grip strength, health related QOL, weather , temperature, humidity
(Safety evaluation)
General physical findings (subjective symptoms, objective findings), vital signs (weight, body temperature, blood pressure, pulse rate), blood test items, urinalysis items, frequency of adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
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 2-weeks intake of SNR14-containing food
Interventions/Control_2 2-weeks intake of the placebo food
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1)Subjects who have obtained written consent for participation in the research.
2)Healthy men and women aged between 20 and 60.
3)Subjects who can take test foods, etc., take blood samples, take urine samples, and stay quiet and rest on the schedule indicated by investigators.
Key exclusion criteria 1)Subjects whose clinical inspection results are outside of the normal range and who are estimated inappropriate to this study.
2)Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study.
3)As a general rule, those who regularly use drugs for the purpose of treating diseases.
4)Subjects who have allergy.
5)Lactating people, pregnant women or those who may be pregnant, and those who wish to become pregnant during the study period.
6)Subjects who are estimated inappropriate to this study by principal investigator or investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yasutaka
Middle name
Last name Ikeda
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuticals Research Institute
Zip code 842-0195
Address 5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga, Japan
TEL 0952-52-1522
Email Ikeda.Yasutaka@otsuka.jp

Public contact
Name of contact person
1st name Tsubasa
Middle name
Last name Mizokami
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuticals Research Institute
Zip code 842-0195
Address 5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL 0952-52-1522
Homepage URL
Email Mizokami.Tsubasa@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Physical Education and Medicine Research Foundation
Name of secondary funder(s)

IRB Contact (For public release)
Organization Otsuka Pharmaceutical Co., Ltd.
Address Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel 03-6717-1499
Email shimizu_se@otsuka.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
2020 Year 11 Month 13 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
2020 Year 11 Month 02 Day
Date of IRB
2020 Year 11 Month 02 Day
Anticipated trial start date
2020 Year 11 Month 07 Day
Last follow-up date
2020 Year 12 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
2020 Year 11 Month 13 Day
Last modified on
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048447

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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