UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019670 |
|---|---|
| Receipt number | R000022568 |
| Scientific Title | Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2016/05/10 11:36:00 |
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Basic information
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
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
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
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
| 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
info@tes-h.co.jp
Public contact
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
info@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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.
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022568
