Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

Exclusion Criteria

• •1. Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study
• •2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products
• •3. Osteoporosis, determined by
• •* Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis)
• •* DXA scans of the lumbar spine between day -14 and day 1 of the study; exclusion threshold is set at -2z score of BMD
• •4. Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans
• •5. Having a history of medical or surgical events that may significantly affect the study outcome, including:
• •* surgical menopause (including hysterectomy)
• •* antecedents and high familiar incidence of breast and/or endometrial cancer
• •* gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study)
• •* hepatic disease (acute or viral hepatitis, chronic hepatitis)
• •* cardiovascular disease and thrombosis
• •* impaired renal function
• •* severe immune disease
• •* endocrine diseases (hyperthyroidism, hyperparathyroidism, IDDM, NIDDM)
• •6. Food allergy as reported by the subject (with special emphasis on soy products) and reported allergy for sunscreen products
• •7. Use of concomitant medication including
• •* Hormonal replacement therapy (during the study and within the last 6 months before day 01 of the study)
• •* Current use of corticosteroids (including Aerosol therapy) or past use for more than 10 days within the last 6 months
• •* Osteoporosis treatment (biphosphonates, SERM's, calcitonin, injectable PTH)
• •* Other medications known to affect bone metabolism (statins). Use of antibiotics will be carefully recorded.
• •8. Change in smoking habits for the last 2 months
• •9. Alcohol consumption \> 21 units (drinks)/week
• •10. Reported unexplained weight loss or gain of \> 5 % of usual body weight in the month prior to the pre-study screening
• •11. Reported slimming or medically prescribed diet
• •12. Professional sportswomen (\> 10 hours extensive sports/week)
• •13. Reported vegan, vegetarian, macrobiotic food intake
• •14. Regular intake of soy based foods (\>2 servings per week). Participation is possible when the subject is prepared to stop consumption from screening until the end of the study
• •15. Taking supplements containing isoflavones, in the 3 months prior to enrolment and during the study. Subjects should not start taking calcium and vitamin D supplements during the study. However, subjects who already take calcium and vitamin D supplements should maintain this intake during the study
• •16. Recent blood or plasma donation (\<1 month prior to the start of the study)
• •17. Not willing to stop blood or plasma donation during the study
• •18. TNO Nutrition and Food Research personnel, their partner and their first and second generation relatives
• •19. Not having a general practitioner
• •20. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health. For example, laboratory results, findings at health and lifestyle questionnaire interview, or physical examination and eventual adverse events communicated to and from their general practitioner
• •21. Mental status incompatible with the proper conduct of the study