Healthy adults
Conditions
Interventions
Daily intake of 150 g of active test food for 8 weeks.
Daily intake of 150 g of placebo food for 8 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with feeling fatigue daily. 2.Subjects with unbalanced dietary habit. 3.Subjects who agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders. 2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 3.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 5.Subjects with severe anemia. 6.Pre- or post-menopausal women complaining of obvious physical changes. 7.Subjects who are at risk of having allergic reactions to drugs. 8.Subjects who take medicine, functional foods, nutritional food, and/or nutritional drink which contain V.A and/or V.D. 9.Subjects who take medicine, functional foods, nutritional food, and/or nutritional drink which contain vitamin other than V.A /V.D and/or mineral (iron, zinc, copper, and selenium). 10.Heavy smokers, alcohol addicts or subjects with eating disordered lifestyle. 11.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 12.Pregnant or lactating women or women who expect to be pregnant during this study. 13.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 14.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chalder fatigue scale at 4 and 8 weeks after beginning the intake of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS questionnaire assessed fatigue, salivary chromogranin A before and after fatigue loading, POMS-2, LF/HF ratio, Alb, TP, A/G ratio, ChE, Hb, MCV, ferritin, UIBC, TIBC, Fe, Zinc, selenium, copper,V.A, V.B1,V.B2,V.B6, V.B12, 1-alpha,25-(OH)2-V.D, V.E, V.C, folic acid, serum cortisol, d-ROM, BAP, food frequency questionnaire, questionnaire assessed feeling after ingesting test food, diary-test food intake situation (taste, ingestion situation, hunger, tiredness, feeling etc.) | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Research Center
Outcome results
None listed