Status:
COMPLETED
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Lead Sponsor:
TNO
Collaborating Sponsors:
European Commission
National Institute for Research on Food and Nutrition
Conditions:
Osteoporosis
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We inve...
Detailed Description
Two hundred and thirty-seven healthy early post-menopausal women (age 53 ± 3 y; time since last menses 33 ± 15 months) consumed isoflavone-enriched foods providing a mean daily intake of 110 mg isofla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00301353
Start Date
October 1 2002
End Date
July 1 2004
Last Update
May 21 2015
Active Locations (3)
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1
Institute National de la Recherche Agronomique
Saint-Genès-Champanelle, France, 63122
2
National Institute for Research on Food an Nutrition
Rome, Italy, 00178
3
TNO Quality of Life
Zeist, Netherlands, 3700 AJ