UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat
Title of the study (Brief title)	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
Condition	N/A (healthy adults or adults with obese tendencies)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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

Research contact person
Name of lead principal investigator	Atsuko Mori
Organization	Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Division name	Internal Department
Address	1-20-11, Ueno, Taito-ku, Tokyo 110-0005 JAPAN
TEL	03-5816-0711
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
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

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Golden Biotechnology Corp.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	RCT Japan Inc.

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	2015 Year 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 06 Day
Last modified on	2016 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022568