UMIN-CTR Clinical Trial

Basic information
Public title	Verification study on the effect of food material intake on abdominal visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Acronym	Verification study on the effect of food material intake on abdominal visceral fat
Scientific Title	Verification study on the effect of food material intake on abdominal visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym	Verification study on the effect of food material intake on abdominal visceral fat
Region	Japan

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

Objectives
Narrative objectives1	To investigate the safety and efficacy of intake of food material for 12 weeks on abdominal fat area reduction in healthy males and females with BMI 23 kg/m2 or more and less than 30 kg/m2
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Body weight,BMI,Waist circumference,hip circumference, W/H ratio,Subcutaneous fat area,total fat area,total cholesterol,LDL- cholesterol,HDL- cholesterol,triglyceride,glucose,HbA1c

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 12 weeks
Interventions/Control_2	Intake of placebo food for 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Japanese Males and females aged of 20-64 years 2)Subjects with BMI >=23 kg/m2 and <30 kg/m2 3)Subjects who can visit on schedule days 4)Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1)Subjects who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs 2)Subjects who dyslipidemia, high blood pressure, or diabetes 3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4)Subjects who regularly use health foods and supplements affecting the study 5)Possible pregnancy, pregnancy and lactation 6)Heavy drinkers 7)Subjects who feel bad mood by blood collect 8)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 9)Those who have been diagnosed with chronic constipation 10)Shift worker 11)Subjects who plan business trip or trip for 10 days or more a month 12)Subjects who have allergy related to the test foods 13)Subjects already participating in other clinical trials 14)Subjects who are ineligible due to physician's judgment
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Ikuo Middle name Last name Fukuhara
Organization	Fukuhara Clinic
Division name	Hospital director
Zip code	061-1351
Address	3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL	0123-36-8029
Email	i-feniwa@gray.plala.or.jp

Public contact
Name of contact person	1st name Tomoya Middle name Last name Yuhki
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Zip code	061-1405
Address	452-1 Toiso,Eniwa,Hokkaido,Japan
TEL	0123-34-0412
Homepage URL
Email	t-yuhki@ndrcenter.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
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	Fukuhara Clinic Clinical Trial Review Committee
Address	1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido
Tel	0123-36-8029
Email	d-kameda@mediffom.co.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	2021 Year 07 Month 02 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 06 Month 23 Day
Date of IRB	2021 Year 06 Month 21 Day
Anticipated trial start date	2021 Year 08 Month 17 Day
Last follow-up date	2021 Year 11 Month 20 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 07 Month 01 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051081