UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022690
Receipt number R000026153
Scientific Title The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial
Date of disclosure of the study information 2016/06/12
Last modified on 2017/02/14 18:11:35

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Basic information

Public title

The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial

Acronym

The effects of test food(HB-h008) on body fat in healthy Japanese adults

Scientific Title

The effects of test food(HB-h008) on body fat in healthy Japanese adults: a randomized, placebo-controlled, double-blind trial

Scientific Title:Acronym

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

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 Makoto Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code


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 or person

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name



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)



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

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


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

2016 Year 04 Month 26 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name