Dose-Finding Study and Assessment of Safety of a Supplement Containing Mushroom Extract for Reducing LDL-C, T-Chom, and Body Fat
- Conditions
- /A (healthy adults or adults with obese tendencies)
- Registration Number
- JPRN-UMIN000019670
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
[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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [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)
- Secondary Outcome Measures
Name Time Method [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