UMIN-CTR Clinical Trial

Public title

Effects of a Supplement Containing Mushroom Chitosan on Reducing Visceral Fat and Promoting Fat Combustion

Acronym

Effects of Mushroom-chitosan-supplement on Metabolic Syndrome

Scientific Title

Effects of a Supplement Containing Mushroom Chitosan on Reducing Visceral Fat and Promoting Fat Combustion

Scientific Title:Acronym

Effects of Mushroom-chitosan-supplement on Metabolic Syndrome

Region

Japan

Condition

Metabolic Syndrome

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate efficacy of a supplement containing mushroom chitosan on reducing visceral fat and promoting fat combustion .

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

CT scanning (visceral fat)

Key secondary outcomes

Body structure
Blood pressure
Pulsation
Hematologic test
Physical measurement
Subject's diary
Doctor's questions
Urine analysis
Diet survey and management

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test product (12 weeks)

Interventions/Control_2

Oral ingestion of the control product (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

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

Criteria A
[1]Japanese males and females aged 30-60 years
[2]Individuals whose BMI is over 25.0 kg/m^2
[3]Individuals whose weight is over 95 kg
[4]Individuals who are healthy and are not poor feeding

Criteria B
[1]Individuals judged appropriate for the study by the principal
[2]Individuals whose BMI is over 25.0 kg/m~2 (except weight shall be under 95 kg)
[3]Individuals judged not decreased appetite or poor feeding by the principal investigator at the screening

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments (ex. supplement derived from mushroom, diet supplement) in the past 1 month or will ingest those foods during the test period
[3]Individuals who are or are posslibly, or are lactating
[4]Individuals who excessively take alcohol
[5]Individuals who have symptoms of allergy to the test product
[6]Individuals who participate in other clinical studies
[7]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[8]Individuals who have a history of hepatitis
[9]Individuals with serious anemia
[10]Individuals who had been administrated contrast material (ex. barium) in the past 2 months or will be administrated during the test period

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Akimasa Matsuyama

Organization

Shirogane EXE Clinic

Division name

Internal Medicine

Zip code

Address

2F Charming Square Shirogane, 6-16-6 Shirogane Minato-ku Tokyo 108-0072, JAPAN

TEL

03-5939-0701

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	TES Holdings Co., Ltd.

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code

Address

6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

info@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

RICOM Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

14

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

04

Month

11

Day

Date of IRB

Anticipated trial start date

2008

Year

04

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

04

Month

14

Day

Last modified on

2015

Year

04

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019804