None listed
Conditions
Interventions
12 weeks).
Oral intake of the placebo product (2 capsules in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-59 years [2]Individuals who are healthy and have no chronic physical disease including skin disease. [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 who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [8] Individuals who experienced unpleasant feeling during blood drawing. [9] Individuals with drug and food allergies. [10] 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). [11] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12] Individuals smoke an average of 21 or more cigarettes per day on a daily basis [13] Individuals who work late night or shift work, or have irregular lifestyle habits. Also, individuals who may change their lifestyle during the examination period. [14] Individuals who are pregnant, lactating, or may become pregnant. [15] Individuals who participated in other clinical studies in the past 3 months. [16] Individuals who are or whose family is engaged in healthy or functional foods. [17] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Existence and its contents of side effects: number of cases and expression rate of side effects (Percentage of cases of side effects among the number of cases analyzed)(During 12 weeks of intake) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes Adverse effects: number of cases and expression rate of adverse effects (Percentage of cases of adverse effects among the number of cases analyzed)(During 12 weeks of intake) Assessment items include physical measurements, physiological tests, blood tests, urinalysis, interview, and subject logbook. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed