None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 20-64 years. 2) Individuals whose written informed consent has been obtained. 3) Individuals who can come to the designated venue for this study and be inspected. 4) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: Individuals 1) currently suffering from any medical condition and undergoing drug treatment. 2) with a current history of mental illness, sleep disorders, hypertension, diabetes, or dyslipidemia, or a history of severe cases of these conditions. 3) with a history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system. 4) who regularly take medication or have a history of taking medication for the treatment of medical conditions within the past month (excluding occasional use for conditions such as headaches, menstrual cramps, or colds). 5) with a BMI of 30 kg/m2 or higher. 6) who may experience allergic reactions to ingredients contained in the test food, or who may experience allergic reactions to other foods or medications. 7) who have donated blood or similar fluids in amounts exceeding 200 mL within the past month, or 400 mL within the past three months. 8) whose daily alcohol consumption exceeds an average of 40 g of alcohol per day for men and 20 g of alcohol per day for women, calculated on a weekly basis. 9) whose daily routines may change during the study period (e.g., night shifts, extended travel). 10) who currently consume, or have consumed within the past three months, health functional foods, health foods, or supplements on a regular basis, or who plan to consume such products during the study period. 11) who are pregnant, breastfeeding, or may become pregnant, or who intend to become pregnant during the study period. 12) currently participating in another clinical trial, or those who have participated in another clinical trial within the past three months. 13) whose family members or themselves are employed by a company that develops, manufactures, or sells health foods, functional foods, or cosmetics. 14) Any other individuals deemed ineligible for this trial by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Existence and its contents of side effects: number of cases and expression rate of side effects (During 12 weeks of intake) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary Endpoints 1) Trends and Changes in Physical Examination Findings (1) -Blood pressure/pulse rate -Weight/body fat percentage/BMI 2) Trends and Changes in Laboratory Test Results (1) -Hematological tests -Biochemical blood tests -General urinalysis 3) Medical consultation (1) 4) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (2) * Exploratory Endpoints 1) Serum anthocyanin concentration (1) (1): Week 0, Week 6, Week 12 (2): During 12 weeks of intake | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed