N/A(healthy adults)
Conditions
Interventions
2 weeks).
Intake of the test meal (3 times in a day
2 weeks) and exercise (10 min. in a day
2 weeks).
Intake of normal meals (keeping habit of eating before participating with the study
2 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese males aged 30-64 years. [2] Individuals whose BMI is not less than 23 kg/m2 and under 30 kg/m2 and visceral fat level is relatively 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 2 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 3 months. [9]Individuals who have a plan to take health checkup from 2 weeks before Week 0 to the last day of the test. [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [11]Individuals who are sensitive to test product or other foods, and medical products. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). [13]Individuals who smoke over 21 cigarettes in a day. [14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15]Individuals who have a habit to use drug claiming to reduce visceral fat and body fat in the past 3 months. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is engaged in health foods of functional foods. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for visceral fat and body fat.(1) (1):Screening, Week 0, Week 1, Week 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Specific blood test(1). [2]Specific saliva test(2). [3]Specific fecal test(2). [4]QOL(2). [5]Specific exhalation test(2). *Safety [1]Blood pressure, pulsation(1). [2]Hematologic test(1). [3]Blood biochemical test(1). [4]Urine analysis(1). [5]Bone density measurement(2). [6]Subject's diary(3). [7]Doctor's questions(1). [8]Side effects and adverse events(2). (1):Screening, Week 0, Week 1, Week 2. (2):Week 0, Week 1, Week 2. (3): Everyday From the seven days before the first day of ingestion of a test material to the last day of the test. *Other indexes Dietary survey (4) (4):Week 0 (for 3 days), Week 2 (for 3 days). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed