UMIN-CTR Clinical Trial

Public title

Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat

Acronym

Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat

Scientific Title

Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat

Scientific Title:Acronym

Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat

Region

Japan

Condition

N/A (healthy adults or adults with obese tendencies)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examine effective dose and safety of a supplyment containing mushroom extract for reducing LDL-C, T-Cho, and body fat for 12 weeks ingestion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]LDL-C (Screening/Week 0, Week 4, Week 8, Week 12)
[2]T-Cho (Screening/Week 0, Week 4, Week 8, Week 12)
[3]Visceral fat measuring (Screening/Week 0, Week 8, Week 12)
[4]Weight, body fat percentage, BMI (Screening/Week 0, Week 4, Week 8, Week 12)
[6]Abdominal girth, hip girth (Screening/Week 0, Week 4, Week 8, Week 12)

Key secondary outcomes

[1]TG
[2]Blood pressure, pulsation
[3]Hematologic test
[4]Blood biochemical test
[5]Urine analysis
[6]Assessment of fatty liver with echo
[7]Questionnaire survey
[8]Dietary survey
[9]Survery of number of steps with a pedometer
[10]Doctor's questions
[11]Subject's diary

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test products containing 25mg muschroom extract (2 grains x 2 times per a day; 12 weeks)

Interventions/Control_2

Oral ingestion of the test products containing 50mg muschroom extract (2 grains x 2 times per a day; 12 weeks)

Interventions/Control_3

Oral ingestion of the test products containing 100mg muschroom extract (2 grains x 2 times per a day; 12 weeks)

Interventions/Control_4

Oral ingestion of the control products not containing mushroom extract (2 grains x 2 times per a day; 12 weeks)

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 30-65 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose T-Cho is 160-240mg/dL and/or LDL-C is 120-160mg/dL
[4]Individuals whose BMI is over 25-30
[5]Individuals whose abdominal girth is over 85cm (males) or 90cm (female)
[6]Individuals whose written informed consent has been obtained
[7]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[3]Individuals who are sensitive to test product or other foods, and medical products
[4]Individuals who have a history of hepatitis
[5]Individuals with serious anemia
[6]Individuals whose amount of dietary intake or exercise has changed significantly in the past one year
[7]Individuals whose weight has changed significantly in the past one year
[8]Individuals whose average number of cigarettes for smoking is over 21/day
[9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[10]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer)
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period
[12]Individuals who participated in other clinical studies in the past three months
[13]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[14]Individuals who are or are posslibly, or are lactating
[15]Individuals judged inappropriate for the study by the principal

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Atsuko Mori

Organization

Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Division name

Internal Department

Zip code

Address

1-20-11, Ueno, Taito-ku, Tokyo 110-0005 JAPAN

TEL

03-5816-0711

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

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

Golden Biotechnology Corp.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

RCT Japan Inc.

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

11

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

2015

Year

10

Month

17

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

07

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

11

Month

06

Day

Last modified on

2016

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022568