None listed
Conditions
Interventions
Oral intake of the test food (2 bottles a day
12 weeks)
Oral intake of the placebo food (2 bottles a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between 20 and 59 years of age at the time of obtaining consent to participate in the study. 2) Individuals who feel stressed or fatigued in their daily lives. 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.
Exclusion criteria
Exclusion criteria: Individuals 1) 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) with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract. 4) with serious anemia. 5) who used a drug to treat a disease in the past 1 month. 6) whose BMI is over 30 kg/m2. 7) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug. 8) 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) with a habit of consuming foods that may affect the study. 10) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent. 11) who are at risk of developing hay fever or other seasonal allergic symptoms and may use pharmaceutical medication or nasal drops. 12) who are a smoker. 13) with irregular lifestyles, such as shift work, night work, etc. 14) with possible changes of life style during the test period. 15) with inflammation or wounds on the fingers. 16) 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. 17) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 18) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 19) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Capillary index (Week 0, Week 6, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary endpoint 1) Autonomic Balance, Accelerated Pulse Wave (1) 2) LOX-index (1) 3) Antioxidant-related index test (1) 4) POMS2 Japanese (abridged version) (1) 5) Lifestyle and Experience Questionnaire (1) * Safety endpoints 1) physical examination ( Blood pressure/beat, weight/body fat percentage/BMI ) (1) 2) Clinical laboratory tests (hematology, blood biochemistry, general urinalysis) (1) 3) Doctor's questions (1) 4) Side effects/ Adverse events (2) 5) Subject's diary ( Adverse event investigation ) (3) (1): Week 0, Week 6, Week 12 (2): Week 6, Week 12 (3): 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