UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027077
Receipt number	R000030935
Scientific Title	A study on the effect of compound supplement on body fat and exhalation metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel Study-
Date of disclosure of the study information	2018/09/01
Last modified on	2019/09/17 14:25:04

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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

Healthy volunteer

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

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

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

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 or person

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030935

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name