UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of the combination of food containing polyphenols and exercise.
Title of the study (Brief title)	Exploratory study of the combination of food containing polyphenols and exercise.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore effects of combination of food containing polyphenols and exercise.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal total fat area, 8 and 12 weeks after investigation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects will take the food containing polyphenols with exercise for 12 weeks.
Interventions/Control_2	Subjects will take the food containing polyphenols without exercise for 12 weeks.
Interventions/Control_3	Subjects will take the food containing no polyphenols with exercise for 12 weeks.
Interventions/Control_4	Subjects will take the food containing no polyphenols without exercise for 12 weeks.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 years of age or older. 2) With no treatment. 3) Submitting the written informed consent before the study.
Key exclusion criteria	1) With previous and present serious disease such as liver disorder, kidney disorder, cardiac affection, lung disorder, digestive disorder, organ disorder, diabetes mellitus, food allergy. 2) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food. 3) Female in pregnancy, lactation and scheduled pregnancy period. 4) Investigator's judgment for other reason
Target sample size	32

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Akifumi Maeda
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0719
Homepage URL
Email	Akifumi_Maeda@suntory.co.jp

Sponsor
Institute	Suntory Business Expert Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 11 Day
Anticipated trial start date	2016 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 28 Day
Last modified on	2017 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026935