UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036590
Receipt number R000041627
Scientific Title Efficacy test of supplements containing plant extract for Japanese
Date of disclosure of the study information 2020/05/08
Last modified on 2019/05/15 09:48:31

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Basic information

Public title

Efficacy test of supplements containing plant extract for Japanese

Acronym

Efficacy test of supplements containing plant extract for Japanese

Scientific Title

Efficacy test of supplements containing plant extract for Japanese

Scientific Title:Acronym

Efficacy test of supplements containing plant extract for Japanese

Region

Japan


Condition

Condition

Healthy Japanese adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to verify the effects on body fat of test foods in adult men and women of BMI 25 and under 30 and abdominal visceral fat area (VFA) 80 cm^2.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body fat percentage and change
Neutral fat and change

Key secondary outcomes

Weight and change
BMI and change
Waist circumference and change
Hip circumference and amount of change


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of plant extract-containing food for 12 weeks

Interventions/Control_2

Intake of plant extract free food 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Persons aged 20 to 65 years of age at the time of obtaining informed consent
2) A healthy person who is not currently treating any disease
3) Persons with BMI of 25.0 kg / m2 or more and less than 30.0 kg / m2 at screening
4) Persons with a VFA of 80 cm2 or more using a CT scanner system
5) Those who can visit the designated medical institution on the scheduled examination date
6) A person who agreed in writing after fully understanding the purpose and content of this study

Key exclusion criteria

1) Those who have difficulty participating in the study due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes (according to the criteria established by the Japan Diabetes Association), and other diseases.
2) Person with a history of cardiovascular disease
3) Those who are taking glucose metabolism, lipid metabolism, blood pressure improvement drugs
4) Those who regularly use medicines and health foods / supplements (including foods for specified health, functional labeling foods and nutritionally functional foods) that may affect this study (but stop taking it at the time of obtaining consent) The person who can do it does not correspond)
5) Persons who have allergies related to the test food
6) Those who have experienced poor mood or physical condition by blood collection in the past
7) Those who donated more than 200 mL from the month before the start of the test to the start of the test
8) Those who are participating in other clinical trials or within 4 weeks after the trial
9) Alcoholic drinkers and excessive smokers
10) Eating habits are extremely irregular
11) Those who wish to become pregnant during the study period, pregnant women (including those who may be pregnant) or those who are lactating
12) Those who can not agree with the purpose of the description of this exam that is conducted in advance
In addition, those who were judged inappropriate for this study by the study investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name Shiojima

Organization

RYUSENDO CO., LTD.

Division name

President and CEO

Zip code

171-0021

Address

1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan

TEL

03-3985-8346

Email

y.shiojima@ryusendo.co.jp


Public contact

Name of contact person

1st name Megumi
Middle name
Last name Takahashi

Organization

RYUSENDO CO., LTD.

Division name

Development Office

Zip code

171-0021

Address

1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan

TEL

03-3985-8346

Homepage URL


Email

m.takahashi@ryusendo.co.jp


Sponsor or person

Institute

KYOWA TRIAL CO., LTD

Institute

Department

Personal name



Funding Source

Organization

RYUSENDO 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

Akanuma Surgeon Board Ethics Review Committee

Address

Ishiyama 2-jo 6-chome 14-1, Minami-ku, Sapporo-shi, Hokkaido

Tel

011-591-1777

Email

s-ito@kyowa-t.com


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

赤沼外科医院(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 08 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

0

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

Terminated

Date of protocol fixation

2019 Year 03 Month 25 Day

Date of IRB

2019 Year 03 Month 26 Day

Anticipated trial start date

2019 Year 05 Month 20 Day

Last follow-up date

2019 Year 08 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 04 Month 24 Day

Last modified on

2019 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name