None listed
Conditions
Interventions
Oral intake of the test food (3 tablets in a day
12 weeks).
Oral intake of the placebo food (3 tablets in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and postmenopausal women who are between 40 and 65 years of age at the time of obtaining consent to participate in the study. 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 with a history or current history of mental illness, sleep disorders, menopausal disorders, hypertension, diabetes, dyslipidemia or serious illness 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung damage and hematological disease. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals with serious anemia. 6) Individuals who used a drug to treat a disease in the past 1 month. 7) Individuals whose BMI is over 30 kg/m2. 8) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug. 9) Individuals who have been taking functional foods, health foods, supplements, etc. on a continuous basis at present or within the past 3 months, and those who are planning to take them during the study period. 10) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 11) Individuals who are a smoker. 12) Individuals who engage in a night work. 13) Individuals with possible changes of life style during the test period. 14) Individuals with inflammation or wounds on the fingers. 15) Individuals who have had more than 200 mL of blood drawn (e.g., blood donation) within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study. 16) Individuals who participated in other clinical studies in the past 3 months. 17) Individuals who are or whose family is engaged in healthy or functional foods. 18) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FMD Measurement(Blood Flow Dependent Vasodilatory Response Test) ( Week 0, Week 12 ) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary indexes 1) Capillary image analysis with capillaroscope (number, length, vessel width, turbidity and nail bed blood flow) (1) 2) Physical examination (Blood pressure, pulsation, Weight, Body fat percentage, BMI) (1) 3) Clinical examination (Hematologic test, Blood biochemical test, Urine analysis) (1) 4) Experience-based questionnaire survey (1) * Safety 1) Doctor's questions / Determination of adverse events and side effects (1) 2) Subject's diary (2) (1): Week 0, Week 6, Week 12 (2): From the first day of ingestion of a test material to the last day of the test | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed