UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on body fat reducing effect of dietary supplement -A randomized, double blind, placebo-controlled, parallel group study-
Title of the study (Brief title)	Study on body fat reducing effect of dietary supplement
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	This study aims to evaluate the effect of the dietary supplement on body fat of subject aged 40 to 64 years with slightly high body mass index (BMI: 23 kg/m2 to less than 30 kg/m2).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Abdominal fat area
Key secondary outcomes	Body weight, BMI, body fat percentage

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of dietary supplement for 12 consecutive weeks
Interventions/Control_2	Intake of placebo for 12 consecutive 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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	1)Vietnamese women between 40 and 65 years old at the time of obtaining informed consent. 2)BMI between 23 and 30kg/m2. 3)Waist circumference of at least 80cm.
Key exclusion criteria	1)The candidate is currently undergoing drug or exercise therapy. 2)The candidate currently has, or has a history of, diabetes, liver disease, kidney disease, heart disease, any disease that affects corticosteroid secretion, and/or any other metabolic disease. 3)There are concerns about the potential for the study foods to induce allergic symptoms in the candidate. 4)The candidate is pregnant, or intends to become pregnant or to breastfeed during the study period. 5)The candidate generally or routinely takes any medication that affects body fat and/or lipid metabolism, including over-the-counter drugs, quasi-drugs, and health foods. 6)The candidate is currently dieting with the aim of reducing body weight. 7)The candidate has participated in any other clinical study within the past 1month.
Target sample size	100

Research contact person
Name of lead principal investigator	Bui Thi Nhung
Organization	National Institute of Nutrition
Division name	-
Address	48B-Tang Bat Ho, Hanoi-Vietnam
TEL	+84-43971-7090
Email	nhungvnnin@gmail.com

Public contact
Name of contact person	Yoshiki Shimizu
Organization	FANCL Corporataion
Division name	Research Institute
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa 244-0806, Japan
TEL	045-820-3755
Homepage URL
Email	shimizu_yoshiki@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
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	2017 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 23 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	2017 Year 09 Month 08 Day
Last modified on	2017 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033231