A Randomized, Double-blind, Placebo-Controlled, Parallel Group Comparison Study on the Effects of Daily Ingestion of Isoflavone -Rich Soybean, "Yukipirika" on the Improvement of Bone Metabolism and Menopausal Symptoms
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000019450
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Simplified Menopausal Index, urinary NTx, urinary DPyr, serum TRACP-5b at 4 and 8 weeks after ingestion of test meals.
- Secondary Outcome Measures
Name Time Method 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