UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030731
Receipt number R000034822
Scientific Title A Study on the Effect of Food Containing Plant Extract on Visceral Fat Area -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2018/01/11
Last modified on 2020/04/17 18:22:20

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Basic information

Public title

A Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

Acronym

A Study on the Effect of Food Containing Plant Extract on Visceral Fat Area

Scientific Title

A Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

Scientific Title:Acronym

A Study on the Effect of Food Containing Plant Extract on Visceral Fat Area

Region

Japan


Condition

Condition

No

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of food containing plant extract on visceral fat area

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, body weight(BMI), Waist circumference, Hip circumference, Waist circumference/Hip circumference


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

Foods containing plant extract

Interventions/Control_2

Foods not containing plant extract

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) Healthy males and females aged 20 to 64 years-old.
(2) Subjects whose BMI are 23 or over and under 30. In case of subjects whose BMI are 25 or over and under 30, their visceral fat area are needed to be less than 100 cm2.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

(1) Subjects who use habitually medications.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism, and so on during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease).
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(7) Subjects who have been implanted metal in the abdominal area, as detected by computerized tomography.
(8) Subjects who have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator).
(9) Subjects who have claustrophobia.
(10) Subjects who are shiftworker and/or midnight-shift worker.
(11) Subjects who have been diagnosed as familial hyperlipidemia.
(12) Subjects who are planning to become pregnant after imformed consent for the current study, pregnant or lactating.
(13) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(14) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Medical examination and treatment management family chief director

Zip code

108-0075

Address

1-2-70 Konan, Minato-ku, Tokyo

TEL

03-3452-3381

Email

satoru_suzuki@sempos.or.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

yoshi@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

TOYO SHINYAKU 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

Ethical Committee of Shinagawa Season Terrace Health Care Clinic

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

Tel

03-3452-3382

Email

tomohiro_kogo@sempos.or.jp


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 01 Month 11 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034822

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/46120/2091

Number of participants that the trial has enrolled

100

Results

Statistically significant difference was confirmed in the primary outcome.

Results date posted

2020 Year 04 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Males and females aged 20 to 64 years old.

Participant flow

Enrolled(n=100)
Completed(n=99)
Analysed(n=84)

Adverse events

No adverse events were observed that be related to test food.

Outcome measures

Visceral fat area

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 11 Month 27 Day

Date of IRB

2017 Year 12 Month 22 Day

Anticipated trial start date

2018 Year 01 Month 13 Day

Last follow-up date

2018 Year 06 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 09 Day

Last modified on

2020 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name