Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Healthy as assessed by the:

health and lifestyle questionnaire
physical examination
results of the pre-study laboratory tests
Caucasian women

Postmenopausal (≥12 - ≤60 months since last menses), determined by

interview
FSH level ≥ 20 IU/l
Body Mass Index (BMI) ≥22 - ≤29 kg/m2
Voluntary participation
Having given their written informed consent
Willing to comply with the study procedures
Willing to accept use of all nameless data, including publication and the confidential use and storage of all data
Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study
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

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
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

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)
Food allergy as reported by the subject (with special emphasis on soy products) and reported allergy for sunscreen products

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.
Change in smoking habits for the last 2 months
Alcohol consumption > 21 units (drinks)/week
Reported unexplained weight loss or gain of > 5 % of usual body weight in the month prior to the pre-study screening
Reported slimming or medically prescribed diet
Professional sportswomen (> 10 hours extensive sports/week)
Reported vegan, vegetarian, macrobiotic food intake
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
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
Recent blood or plasma donation (<1 month prior to the start of the study)
Not willing to stop blood or plasma donation during the study
TNO Nutrition and Food Research personnel, their partner and their first and second generation relatives
Not having a general practitioner
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
Mental status incompatible with the proper conduct of the study