UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036031
Receipt number R000040934
Scientific Title A Dose Finding 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 2019/03/01
Last modified on 2021/02/18 14:00:49

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Basic information

Public title

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

Acronym

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

Scientific Title

A Dose Finding 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 Dose Finding 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 confirm the effect 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

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Food containing low-dose plant extract

Interventions/Control_2

Food containing medium-dose plant extract

Interventions/Control_3

Food containing high-dose plant extract

Interventions/Control_4

Food not containing plant extract

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.
(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, hyperglycemia, 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., liver disease, 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

120


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Sekiguchi

Organization

Urayasu Sekiguchi Clinic

Division name

Director

Zip code

279-0004

Address

5-17-27 Nekozane, Urayasu-shi, Chiba

TEL

047-306-3557

Email

scfira@royal.ocn.ne.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 Nihonbashi Cardiology Clinic

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

Tel

03-5641-4133

Email

niho-jimucho@well-sleep.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

2019 Year 03 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

2019 Year 02 Month 08 Day

Date of IRB

2019 Year 02 Month 08 Day

Anticipated trial start date

2019 Year 03 Month 02 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 27 Day

Last modified on

2021 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040934


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name