Healthy Japanese subjects
Conditions
Interventions
Daily intake of test food for 12 weeks
Daily intake of placebo(control food)for 12 weeks
Sponsors
APO PLUS STATION CO., LTD.
Medical Corporation Watanabe Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Persons who are judged by the investigator to be eligible to participate in the study. (2) Persons with relatively poor fatigue VAS values. (3) Persons who selected a response other than "I want to commit suicide" or "I intend to commit suicide if given a chance" in question 9 of the Physician Diagnosis and BDI-II Beck Depression Questionnaire. (4) Persons who have signed a consent form prior to the start of the study upon full explanation of the purpose and content of the study.
Exclusion criteria
Exclusion criteria: (1) Persons who suffer from or have a history of serious heart disease, lung disease, gastrointestinal disease (esophagus, stomach, small intestine, large intestine, liver, kidney, etc.), hypertension, diabetes, malignant tumor, etc. (2) Persons with food allergies or who may be allergic to the test food. (3) Persons who regularly use licensed drugs or quasi-drugs that may affect the study. (4) Persons who regularly use health foods (food for specified health uses, food with nutrient function claims, food with functional claims, supplements, etc.) that may affect the study. (5) Persons who may be unable to discontinue the current drugs intake of pharmaceutical (excluding drugs used as needed), quasi-drugs, or health foods (food for specified health uses, food with nutrient function claims, food with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study. (6) Persons who on work day and night shifts and those who are scheduled to work on night shift during the period of the study. (7) Persons who are attending hospital for mental disorders (depression, etc.) or sleep disorders, or have a history of mental illness in the past. (8) Persons whose drink more than 100 g of alcohol equivalent per week. (9) Persons who drink alcohol more than 5 days per week. (10) Persons who smoke more than 20 cigarettes per day. (11) Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent. (12) Persons who plan to participate in other examinations during the study. (13) Persons who may be unable to maintain their daily lifestyle (diet, exercise, alcohol consumption, smoking, etc.). (14) Persons who have difficulty in intaking study food as directed. (15) Persons who ones pregnant or breast feeding or planning to become pregnant during the study. (16) Persons who are deemed inappropriate for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| POMS2 OSA-MA Acceleration pulse wave measurement (autonomic nervous system, etc.) BDI-II blood cortisol DHEA-s DHEA-s/blood cortisol ratio neutrophil/lymphocyte ratio fatigue (daily life log) malaise (daily life log) | — |
Countries
Japan
Contacts
Public ContactMisaki Sakata
APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division
Outcome results
None listed