UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Test of the visceral fat reduction effect of food ingredient
Title of the study (Brief title)	Test of the visceral fat reduction effect of food ingredient
Region	Japan

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

Objectives
Narrative objectives1	To confirm the visceral fat reduction efficacy and safety of food ingredient
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal visceral fat area at 8th week, 12th week of intake
Key secondary outcomes

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	Ingredient-containing food, 12 weeks
Interventions/Control_2	Ingredient-free food, 12 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 years of age or older. 2) 25 kg/m2 <= BMI < 30 kg/m2. 3) Submitting the written informed consent before this study.
Key exclusion criteria	1) With continuous treatment 2) With previous and present serious disease such as liver disorder, kidney disorder, cardiac affection, lung disorder, digestive disorder, organ disorder, diabetes mellitus, food allergy. 3) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food. 4) Female in pregnancy, lactation and scheduled pregnancy period. 5) Investigator's judgment for other reason.
Target sample size	130

Research contact person
Name of lead principal investigator	Takayuki Izumo
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0630
Email	Takayuki_Izumo@suntory.co.jp

Public contact
Name of contact person	Masayuki Ida
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0752
Homepage URL
Email	Masayuki_Ida@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 14 Day
Anticipated trial start date	2016 Year 07 Month 21 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 20 Day
Last modified on	2017 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026798