Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health

Exclusion Criteria

• •T-score \< -2.5 at total hip and spine (either or both)
• •Suspect lack of compliance
• •BMI \> 30 or \< 21
• •Use of HRT within the previous 6 months
• •Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months
• •Systematic practice of high intensity exercise
• •Vegetarian nutrition or any other extreme dietary habits
• •Use of dietary supplements while on study, except multi vitamin. No "wash out" period for supplements - must stop before run-in period and refrain until the end of the study.
• •Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0).
• •Total genistein blood concentrations of \> 100 ng/ml measured at pre-study examination
• •Known hypersensitivity or allergy to soy, purified isoflavones, peanuts, fish, and/or genistein.
• •Hepatitis screen (serology) positive or not performed
• •Drug screen positive or not performed (at least amphetamines, benzodiazepines, cannabinoides, opiates).
• •Subjects on a weight reduction program or a medically supervised diet
• •Unexplained weight loss or weight gain of more than 5 kg in the three months prior to the study
• •History of liver or pancreas diseases
• •Cardiovascular diseases, even AV-block I0 (PQ time \> 220 ms) and QTc time \> 450 ms
• •History of breast cancer, endometrial cancer and other malignancy except basal and squamous cell skin cancer
• •History of thromboembolism or deep venous thrombosis
• •Any fractures within one year except for fingers, toes and facial bones
• •Subjects with susceptibility for fractures as a history of being a faller
• •Endometrial thickness \> 6 mm
• •Endometrial polyps
• •Untreated hypo- or hyperthyroidism
• •Insulin-dependent diabetes mellitus, Crohn's Disease, Cushing Disease etc.
• •Any condition which might interfere with absorption of the investigational product (e.g. malabsorption syndrome)
• •Co-medication: Anticoagulants, parathyroid hormones, corticosteroids, thiazide diuretic
• •Subjects who, during the previous 24 months, received a total fee payment greater than 5'000 USD for participation in biomedical research