Healthy adults
Conditions
Interventions
Ingestion of 8.5g of "
Yukipirika"
soybean flakes daily for 8 weeks.
Ingestion of 8.5g of "
Fukuyutaka"
soybean flakes daily for 8 weeks.
Ingestion of 8.5g of wheat flakes daily for 8 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Subjects who have subjective symptoms of menopause. 2. Subjects whose serum TRACP-5b is >=309 mU/dl and <=760mU/dl. 3. Subjects who agree to participate in the current study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under treatment and medication for menopausal symptoms, osteoporosis and thyroid disease. 2. Subjects who are under treatment and medication for psychiatric disorders. 3. Subjects who are considered to have secondary osteoporosis (due to endocrine disorders, continuous use of steroids, etc.). 4. Subjects whose urinary productivity of equol is low. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, or gastrointestinal diseases, or affected with infectious diseases which are required to report to the authorities. 6. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure or abnormal hematological data. 8. Subjects with serious anemia. 9. Subjects who are at risk of having allergic reactions to drugs or foods (especially soybean and wheat). 10. Subjects who regularly take medicine, functional foods and/or supplements (isoflavone, daidzein, genistein, glycitein, equol, pycnogeno, onion, maca, etc.) which would improve menopausal symptoms. 11. Subjects who regularly take medicine, functional foods and/or supplements (isoflavone, calcium, magnesium, CBP, MBP, vitamin D, etc.) which would affect the bone metabolism. 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle 13. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 14. Subjects who participate in other clinical trials within the last one month prior to the this study. 15. Any other medical reasons judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simplified Menopausal Index, urinary NTx, urinary DPyr, serum TRACP-5b at 4 and 8 weeks after ingestion of test meals. | — |
Secondary
| Measure | Time frame |
|---|---|
| TC,LDL-C,HDL-C,TG, arteriosclerosis index, E2, FSH,TIBC,UIBC, conditions of skin and hair, functions of joints, VAS scores of bowel movements, BW,BMI and BFR | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Center of Health Information Science
Outcome results
None listed