None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females aged 20 years or older but under 65 years at the time of obtaining consent to participate in the trial. 2) Healthy individuals without chronic physical conditions, including skin diseases. 3) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer for participation after thorough understanding, and can provide written consent to participate in this trial. 4) Individuals who can attend the designated examination date and undergo the examination. 5) Individuals deemed suitable for participation in this trial by the principal investigator.
Exclusion criteria
Exclusion criteria: 1) Individuals currently suffering from any disease and undergoing drug treatment. 2) Individuals with a current medical history involving the digestive organs, liver, kidneys, heart, lungs, mental disorders, sleep disorders, blood disorders, etc., or individuals with a history of serious diseases. 3) Individuals who habitually took medication for disease treatment within the past month (excluding occasional use for headaches, menstrual pain, colds, etc.). 4) Individuals with severe anemia. 5) Individuals with a BMI below 18.5 kg/m2 or above 30 kg/m2. 6) Individuals with systolic blood pressure of 140 mmHg or higher, diastolic blood pressure of 90 mmHg or higher, or pulse rate of 85 beats per minute or higher. 7) Individuals who have donated blood exceeding 200 mL within the past month or 400 mL within the past three months. 8) Individuals who have previously experienced discomfort or deterioration in physical condition following blood collection. 9) Individuals with drug (including alcohol) or food allergies. 10) Individuals regularly consuming specific health foods, foods with functional claims, or health supplements (excluding those who can suspend intake during the trial period at the time of consent). 11) Individuals whose average weekly alcohol consumption exceeds 40g/day for men or 20g/day for women (pure alcohol equivalent). 12) Individuals whose lifestyle may change during the trial period (e.g., due to extended travel). 13) Individuals who are pregnant, breastfeeding, or who may become pregnant during the trial period. 14) Individuals currently participating in another human clinical trial, or individuals who have completed another human clinical trial within the past 3 months. 15) Individuals whose self or family members are employed by companies developing, manufacturing, or selling health/functional foods or cosmetics. 16) Other individuals deemed unsuitable for this trial by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: expression number of cases/number of cases analyzed) . (Week 0, Week 2, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Adverse events: number of cases and expression rate of adverse events (expression rate: expression number of cases / number of cases analyzed).(1) 2)Blood pressure, pulsation. (1) 3)Weight, body fat percentage, BMI. (1) 4)Hematologic test. (1) 5)Blood biochemical test. (1) 6)Urine analysis. (1) 7)Doctor's interview. (1) 8)Subject diary. (2) (1): Week 0, Week 2, Week 4 (2): Record daily from the start of test food intake until the end of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed