N/A (healthy adults)
Conditions
Interventions
12 weeks).
Intake of the test meal (3 times in a day
12 weeks) and exercise (10 min. in a day
12 weeks) and oral intake of a supplement A (3 tablets in a day
12 weeks) and oral intake of a supplement B (1 tablet in a day
12 weeks) and oral intake of a beverage (1 bottle [600 ml] in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 35-65 years. [2]Individuals whose BMI is more than 23.0 kg 2 and less than 30.0 Kg 2 and visceral fat is high. [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 who cannot continue to eat a test meal for 12 weeks. [2]Individuals who are in constipation. [3]Individuals using medical products. [4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who used or applied a drug for treatment of disease in the past 1 month. [6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7]Individuals who contract or have a history of serious endocrine disease. [8]Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month. [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [10]Individuals who are sensitive to test product or other foods, and medical products. [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [13]Individuals who have a habit to use drug claiming to reduce visceral fat and body fat in the past 3 months. [14]Individuals who are or are possibly, or are lactating. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or whose family is engaged in health foods of functional foods. [17]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for body fat(1) and QOL(2) (1)Week 0, Week 4, Week 8, Week 12. (2)Week 0, Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Specific blood test(1). [2]Specific saliva test(1). [3]Specific fecal test(1). [4]Specific urinary test(1). *Safety [1]Blood pressure, pulsation(2). [2]Hematologic test(2). [3]Blood biochemical test(2). [4]Urine analysis(2). [5]Bone density measurement(1). [6]Subject's diary(3). [7]Doctor's questions(2). [8]Side effects and adverse events(4). (1): Week 0, Week 12. (2): Week 0, Week 4, Week 8, Week 12. (3): From the first day of ingestion of a test material to the last day of the test. (4): Week 4, Week 8, Week 12. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed