N/A (healthy adults)
Conditions
Interventions
Sponsors
TES Holdings co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 35-64 years. [2]Individuals whose BMI is not less than 23 kg/m2 and under 30 kg/m2. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can visit an inspection facility and be inspected in designated days. [5]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used or applied a drug for treatment of disease in the past 1 month. [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [5]Individuals who are a patient or have a history of or endocrine disease. [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 60mg/day). [10]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [11]Individuals having a habit to intake a food containing same components with the test food in the past 3 months. [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, 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 health foods of functional foods. [16]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Changes of visceral fat area measured by FatScan software on a CT image (Week 0, Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Changes of subcutaneous fat area and total fat area measured by FatScan software on a CT image (Week 0, Week 12). [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8, Week 12). [3]Waist girth, hip girth / waist-hip ratio (Screening, Week 0, Week 4, Week 8, Week 12). *Safety [1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12). [2]Hematologic test (Screening, Week 0, Week 4, Week 8, Week 12). [3]Blood biochemical test (Screening, Week 0, Week 4, Week 8, Week 12). [4]Urine analysis (Screening, Week 0, Week 4, Week 8, Week 12). [5]Doctor's questions (Screening, Week 0, Week 4, Week 8, Week 12). [6]Subject's diary (From the first day of ingestion of a test material to the last day of the test). *Other indexes [1]Evaluation of abdominal fat by impedance method (Screening). [2]Dietary survey (3 days prior to each inspection date). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed