N/A (healthy adults or adults with obese tendencies)
Conditions
Interventions
Oral ingestion of the test products containing 25mg muschroom extract (2 grains x 2 times per a day
12 weeks)
Oral ingestion of the test products containing 50mg muschroom extract (2 grains x 2 times per a day
12 weeks)
Oral ingestion of the test products containing 100mg muschroom extract (2 grains x 2 times per a day
12 weeks)
Oral ingestion of the control products not containing mushroom extract (2 grains x 2 times per a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [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
| Measure | Time frame |
|---|---|
| [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 | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed