N/A (healthy adults)
Conditions
Interventions
12 weeks)
Oral intake of the placebo drink (200mL in a day
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and Females aged 20-74 years [2]Individuals whose BMI is 23-29 [3]Individuals whose written informed consent has been obtained [4]Individuals who can have an examination in a designated day [5]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals who are visceral fat type obesity defined in Guidelines for the Management of Obesity Disease. [2]Individuals using medical products. [3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [4]Individuals who used or applied a drug for treatment of disease in the past 1 month. [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6]Individuals who are a patient or have a history of or endocrine disease. [7]Individuals whose BMI is over 30. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals with serious anemia. [10]Individuals who are sensitive to test product or other foods, and medical products. [11]Individuals having a habit to intake foods containing components which are contained in the test product. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [14]Individuals having a habit to intake a drink containing citrus juice. [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing hesperidin and nobiletin in the past 3 months or will ingest those foods during the test period. [16]Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Abdominal visceral fat mass (Week 0, Week 8, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Weight, body fat percentage, BMI (Week 0, Week 8, Week 12) [2]Abdominal girth (Week 0, Week 8, Week 12) [3]Blood test (adiponectin) (Week 0, Week 8, Week 12) [4]Questionnaire survey (Week 0, Week 8, Week 12) *Safety [1]Blood pressure, pulsation (Week 0, Week 8, Week 12) [2]Hematologic test (Week 0, Week 8, Week 12) [3]Blood biochemical test (Week 0, Week 8, Week 12) [4]Urine analysis (Week 0, Week 8, Week 12) [5]Doctor's questions (Week 0, Week 8, Week 12) *Other outcomes [1]Dietary survey (3 days prior to each inspection date) [2]Subject's diary(From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd Department of Development for Clinical Trials
Outcome results
None listed