UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Visceral fat-reducing effect of food containing the milk-derived ingredient
Title of the study (Brief title)	Visceral fat-reducing effect of food containing the milk-derived ingredient
Region	Japan

Condition
Condition	No (healthy adults)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the visceral fat-reducing effect of food containing the milk-derived ingredient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Subcutaneous fat area, Total fat area, Waist circumference, Hip circumference, Body weight, BMI

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	Food containing the milk-derived ingredient, 12 weeks
Interventions/Control_2	Food non-containing the milk-derived ingredient, 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 20 to 64 years old at the time of acquiring consent. (2) Subjects whose BMI are 23 to 29.9 at the screening test. (3) Subjects with visceral fat areas of more than 70 cm2 at the screening test. (4) Subjects who provided written informed consent.
Key exclusion criteria	(1) Subjects with the metabolic syndrome. (2) Subjects who have taken medication or surgery due to serious illness or injury within one month before the start of the study. (3) Subjects who have serious diseases in the heart, liver, kidney or digestive organs in the present or past. (4) Subjects who take a medicine for hyperglycemia, hyperlipidemia or hypertension. (5) Subjects who regularly use drugs or functional foods affecting the study. (6) Subjects who are pregnant or lactating. (7) Heavy drinkers or heavy smokers. (8) Subjects with milk allergy. (9) Subjects who are judged as unsuitable for the study by the investigator for the other reason.
Target sample size	140

Research contact person
Name of lead principal investigator	Ikuo Fukuhara
Organization	Fukuhara Clinic
Division name	Director
Address	3-1-15, Shima-matsuhigashi machi, Eniwa-shi, Hokkaido, Japan
TEL	0123-36-8029
Email	i-feniwa@gray.plala.or.jp

Public contact
Name of contact person	Shimpei Tomita
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Address	452-1, Toiso, Eniwa-shi, Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	s-tomita@ndrcenter.co.jp

Sponsor
Institute	New drug research center, Inc.
Institute
Department

Funding Source
Organization	LION 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	福原医院（北海道）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 08 Day
Anticipated trial start date	2018 Year 03 Month 06 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	2018 Year 03 Month 02 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036020