UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial
Title of the study (Brief title)	The effects of test food(HB-h008) on body fat in healthy Japanese adults
Region	Japan

Condition
Condition	healthy humans
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test food(HB-h008) on body fat area in healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body fat area(Visceral fat area, Subcutaneous fat area, Total fat area) Measuring: at 0 week, 6 weeks and 12 weeks after ingestion
Key secondary outcomes	Weight, BMI, Waist circumference, Hip circumference, Blood glucose, Insulin, Glycoalbumin Measuring: at 0 week, 6 weeks and 12 weeks after ingestion

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	Oral ingestion of the placebo control food once daily for 12 weeks
Interventions/Control_2	Oral ingestion of the test food(HB-h008) once daily 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) 20<=Age<60 of healty men and women (2) 23<=BMI<30
Key exclusion criteria	(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases (2) Subjects who indicate disorder of heart and lung function (3) Subjects who indicate abnormal parameter in liver or kidney function (4) Subjects who had a gastrointestinal surgery (5) Subjects with a disease under treatment now (6) Subjects with drug or food allergy (7) Subjects who play high intensity sports or are on a diet (8) Subjects who have a weight change: 2 kg or more when comparing to 1 month prior to the start of the trial (9) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods (10) Subject who consume exscessive alcohol (11) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period (12) Subjects who is participating in the other study or plannning to participate during the study period (13) Subjects who isdeemed unsuitable by the principal investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal medicine
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	info@miura-cl.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	Hayashibara Co., LTD.
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	医療法人花音会みうらクリニック（大阪府）　Miura Clinic, Medical Corporation Kanonkai（Osaka）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 26 Day
Anticipated trial start date	2016 Year 06 Month 14 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 06 Month 10 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026153