UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042438
Receipt number 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 2021/11/15 08:27:28

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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 or person

Institute

Otsuka Pharmaceutical Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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