None listed
Conditions
Interventions
Oral intake of the test food (4 tablets in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between 20 and 89 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 who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing. 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 with chronic diseases and individuals undergoing treatment for any disease. 2) Individuals with a history or current history of chronic fatigue syndrome, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness. 3) Individuals with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract. 4) Individuals with serious anemia. 5) Individuals who used a drug to treat a disease in the past 1 month. 6) Individuals whose BMI is over 30 kg/m2. 7) Individuals who may develop allergic symptoms to any of the ingredients in the test food, or who may develop allergic symptoms to any other food or drug. 8) Individuals who are currently, or have been within the past 3 months, habitual consumers of food for specified health uses, functional foods, health foods, supplements, etc., or who plan to consume such foods during the study period. 9) Individuals whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent. 10) Individuals who are a smoker. 11) Individuals who work late night or shift work, or have irregular lifestyle habits. 12) Individuals with possible changes of life style during the test period. 13) Individuals with a blood draw of 200 mL within 1 month of the start of this study or 400 mL or more within 3 months of the start of this study. 14) Individuals who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 15) Individuals who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 16) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Exploratory endpoints 1) Physical Function Related Tests 2) Terminal glycation product measurement 3) Blood, urine, saliva, fecal special examination 4) Sleep-related indicators 5) Safety Assessment Related Indicators | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed