None listed
Conditions
Interventions
Oral intake of the test food (2 bottles in a day
8 weeks).
Oral intake of the placebo food (2 bottles 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 64 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 with transient fatigue in daily life (transient fatigue from work, housework, schoolwork, etc.) 4) 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. 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 illnesses and individuals undergoing treatment for any illness. 2) Individuals with a history or current history of chronic fatigue syndrome, mental illness, 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 with a habit of taking or applying drugs for the purpose of disease treatment in the past month. 6) Individuals whose BMI is over 30 kg/m2. 7) Individuals who may develop allergic symptoms to any ingredient in the tested food, or 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 with irregular lifestyles, such as shift work, night work, etc. 11) Individuals with possible changes of life style during the test period. 12) 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. 13) Individuals who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 14) Individuals who work for companies that develop, manufacture or sell health and functional foods and cosmetics for themselves or their family members. 15) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue VAS Survey (Week 0, Week 4, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary endpoints 1) Questionnaire survey using VAS method(1) 2) Chalder Fatigue Scale(1) 3) POMS2 Japan version (all terms version)(1) * Safety Endpoints 1) Blood pressure, pulsation(2) 2) Weight, body fat percentage, BMI(2) 3) Doctor's questions(2) 4) Adverse events(3) 5) Subject's diary(4) (1):Week 0, Week 4, Week 8 (2):Week 0, Week 8 (3):Week 8 (4):Listed daily from the start of the home survey to the end of the exam | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed