UMIN-CTR Clinical Trial

Basic information
Public title	Effect of test food on visceral fat area. (pilot study) Randomized, single-blind, placebo-controlled, parallel-group controlled trial
Acronym	Effect of test food on visceral fat area.
Scientific Title	Examination of changes in visceral fat area due to long-term intake of test foods. Randomized, single-blind, placebo-controlled, parallel-group controlled trial
Scientific Title:Acronym	Examination of changes in visceral fat area due to long-term intake of test foods
Region	Japan

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

Objectives
Narrative objectives1	Examination of changes in visceral fat area due to long-term intake of test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal visceral fat area (VFA) Time;0w, 8w, 16w, 24w
Key secondary outcomes	Total abdominal fat area Abdominal subcutaneous fat area Body weight BMI Waist circumference Hip circumference Waist circumference / Hip circumference Time:0w, 8w, 16w, 24w

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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	Test Food Period:24 weeks
Interventions/Control_2	Control Food (Placebo) Period:24 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	30 years-old <=
Age-upper limit	74 years-old >=
Gender	Male
Key inclusion criteria	1. Age:30 to 74 years old 2. Healthy men 3. BMI: 23-30 kg/m^2
Key exclusion criteria	1.Subjects with a history of serious illness 2.Subjects with inborn errors of amino acid metabolism 3.Subjects who are on medication for diabetes 4.Subjects with diseases that require treatment or medication that affect the study 5.Subjects with regularly use medicines and health foods that affect research 6.Subjects with significant weight changes within the last 6 months (plus or minus 10% or more) 7.Subjects with food allergy to test food 8.Subjects who consume a large amount of alcohol on a daily basis (pure alcohol 60 g/day or more) 9.Subjects who have participated in or are willing to participate in clinical trial 10.Subjects judged as unsuitable for the study by the responsible doctor for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3443
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Goto
Organization	Kenkoin Medical Corporation Foundation
Division name	Kenkoin Clinic
Zip code	104-0061
Address	6-7-4 Ginza, Chuo-ku, Tokyo
TEL	03-3573-1153
Homepage URL
Email	akiko-goto@kenkoin.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)

IRB Contact (For public release)
Organization	Kenkoin Medical Corporation Foundation Clinical Research Ethics Committee
Address	6-7-4 Ginza, Chuo-ku, Tokyo
Tel	03-3573-1153
Email	isamu-yanase@kenkoin.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	医療法人財団健康院　健康院クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 24 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	2021 Year 08 Month 25 Day
Date of IRB	2021 Year 08 Month 31 Day
Anticipated trial start date	2021 Year 09 Month 28 Day
Last follow-up date	2022 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 22 Day
Last modified on	2022 Year 09 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052000