None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study. 2) Standard Japanese who are healthy and free from chronic physical diseases. 3) Individuals with physical or mental fatigue on a daily basis. 4) Individuals whose written informed consent has been obtained. 5) Individuals who can come to the designated venue for this study and be inspected. 6) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 1) Individuals with chronic fatigue. 2) Individuals using medical products. 3) Individuals with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness. 4) Individuals with a serious history of liver, kidney, heart, lung, blood, etc. 5) Individuals with co-morbidities and serious history of gastrointestinal diseases. 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) Alcoholics or those whose daily alcohol consumption exceeds an average weekly alcohol equivalent of 60 g/day. 10) Individuals with possible changes of life style during the test period. 11) 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. 12) Pregnant, lactating, or of childbearing potential or intention to become pregnant during the study period. 13) Individuals who participated in other clinical studies in the past 3 months. 14) Individuals who are or whose family is engaged in healthy or functional foods. 15) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue-related indicators (Week 0, Week 2, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes 1) Autonomic Nervous System Measurement (1) 2) Stress-related indicators in saliva (1) *Safety 1) Physical examinations (1) 2) Clinical examinations (2) 3) Doctor's questions / Adverse events (1) 4) Subject's diary (3) (1): Week 0, Week 2, Week 4 (2): Week 0, Week 4 (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