UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 11 Month 15 Day

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