N/A(healthy adults)
Conditions
Interventions
Oral intake of the test product (10 capsules in a day
4 weeks).
Oral intake of the placebo product (10 capsules 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 for pollenosis). [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 60mg/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 |
|---|---|
| [1]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). *Other index [1]Subject's diary (each day during the test period). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed