UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of compound supplement on body fat and exhalation metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel Study-
Acronym	A study on the effect of compound supplement on body fat and exhalation metabolism
Scientific Title	A study on the effect of compound supplement on body fat and exhalation metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel Study-
Scientific Title:Acronym	A study on the effect of compound supplement on body fat and exhalation metabolism
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the compound supplement
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area, Subcutaneous fat area, Total fat area, Waist circumference, Hip circumference,Exhalation data
Key secondary outcomes	Blood biochemistry, Body weight, Body mass index

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Study food1 12weeks
Interventions/Control_2	Study food2 12weeks
Interventions/Control_3	Placebo 12weeks
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)20<=Age<=59 of healthy males and females (2)23<=BMI<30
Key exclusion criteria	(1)Under treatment and/or have medical history of diabetes, liver disease, renal disease, gastrointestinal disease, peripheral vascular disease and/or other serious disease (2)Subjects who may be allergic reaction to any component of the test foods (3)Cardiopulmonary impairment (4)Hepatic impairment and/or renal impairment (5)Medical history of gastrointestinal surgery (6)Subjects who are under treatment (7)Having allergy to some foods and/or some drugs (8)Exercising intensely and/or on a diet (9)The weight is easy to fluctuate and/or the weight fluctuates more than plus or minus 2kg as compared with one month ago when the study begins (10)Taking functional foods, supplements and/or drugs that might affect the study (11)Heavy drinker and/or cannot stop drinking each measurement day and its previous day (12)Women who are pregnant, may become pregnant and/or nursing mothers (13)Participating subject of other clinical study and/or having a plan during this study period (14)Judged as unsuitable for the study by the investigator
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal medicine
Zip code
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	1st name Middle name Last name Yuko Takahashi
Organization	HABA Laboratories,Inc.
Division name	Life Science Research Institute Analysis Center
Zip code
Address	7F HABA Build. 1-24-11 Kanda Suda-Cho Chiyoda-ku, Tokyo Japan
TEL	03-5296-8724
Homepage URL
Email	y_takahashi@haba.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	HABA Laboratories,Inc.
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
Address
Tel
Email

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	2018 Year 09 Month 01 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	2017 Year 03 Month 21 Day
Date of IRB	2017 Year 03 Month 22 Day
Anticipated trial start date	2017 Year 04 Month 24 Day
Last follow-up date	2017 Year 09 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 20 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030935