None listed
Conditions
Interventions
8 weeks).
Oral intake of the placebo product (1 packet in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 30-59 years 2) Individuals whose BMI is not less than 25 kg/m2 and under 30 kg/m2. 3) Individuals whose written informed consent has been obtained 4) Individuals who can come to the designated venue for this study and be inspected. 5) Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals who used a drug to treat a disease in the past 1 month. 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 6) Individuals who have gained or lost 2 kg of body weight in the past 3 months. 7) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 8) Individuals who are sensitive to test product or other foods, and medical products. 9) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 10) Individuals with possible changes of lifestyle during the test period. 11) Individuals who currently or within the past 3 months have a habit of continuously taking health foods containing persimmon peel extract, or who plan to take them during the test period. 12) Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months. 13) Individuals who are or are possibly pregnant or are lactating. 14) Individuals who participated in other clinical studies in the past 3 months. 15) Individuals who are or whose family is engaged in healthy or functional foods. 16) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Indexes for body fat 1) FatScan measurement of abdominal fat mass using CT scan images. (1) 2) Body composition. (Weight, body fat percentage, BMI) (2) (1): Week0, Week8 (2): Week0, Week4, Week8 | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes 1) Body composition. (Other Related Indicators) (1) 2) Waist girth, hip girth / waist-hip ratio (1) 3) Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ) (1) 4) Specific blood test (1) *Safety indexes 1) Blood pressure, pulsation(1) 2) Hematologic test (1) 3) Blood biochemical test (1) 4) Urine analysis (1) 5) Doctor's questions (1) 6) Side effects/ Adverse events (2) 7) Subject's diary (3) (1): Week0, Week4, Week8 (2): Week4, Week8 (3): From the first day of ingestion of a test material to the last day of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed