None listed
Conditions
Interventions
Oral intake of the test food (20 tablets in a day
4 weeks).
Oral intake of the placebo food (15 tablets in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Males and females aged 20-64 years. 2)Individuals who are healthy and have no chronic physical disease including skin disorder. 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 are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 3)Individuals who used a drug to treat a disease in the past 1 month (except temporal usage forpollenosis). 4)Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 5)Individuals who are a patient or have a history of or endocrine disease. 6)Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2. 7)Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. 8)Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 9)Individuals who experienced unpleasant feeling during blood drawing. 10)Individuals who are sensitive to the test food. 11)Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). 12)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 13)Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. 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 functional foods or cosmetics. 17)Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4). [2]Blood pressure, pulsation (Week 0, Week 2, Week 4). [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4). [4]Hematologic test (Week 0, Week 2, Week 4). [5]Blood biochemical test (Week 0, Week 2, Week 4). [6]Urine analysis (Week 0, Week 2, Week 4). [7]Doctor's questions (Week 0, Week 2, Week 4). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed