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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301353
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : May 21, 2015
European Commission
National Institute for Research on Food and Nutrition
Institut National de la Recherche Agronomique
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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 investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Isoflavones-enriched foods Not Applicable

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 isoflavone aglycones or control products for 1 yr whilst continuing their habitual diet and lifestyle. Outcome measures included bone mineral density of lumbar spine and total body, markers for bone formation and bone resorption, hormones, isoflavones in plasma and urine, safety parameters and reporting of adverse events.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Study Start Date : October 2002
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. Bone mineral density of total body and lumbar spine (DXA)

Secondary Outcome Measures :
  1. Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
  2. Hormones (estradiol, FSH, LH, SHBG)

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy as assessed by the:

    • health and lifestyle questionnaire
    • physical examination
    • results of the pre-study laboratory tests
  2. Caucasian women
  3. Postmenopausal (≥12 - ≤60 months since last menses), determined by

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301353

Institute National de la Recherche Agronomique
Saint-Genes Champanelle, France, 63122
National Institute for Research on Food an Nutrition
Rome, Italy, 00178
TNO Quality of Life
Zeist, Netherlands, 3700 AJ
Sponsors and Collaborators
European Commission
National Institute for Research on Food and Nutrition
Institut National de la Recherche Agronomique
Principal Investigator: Elizabeth Brink, PhD TNO

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00301353     History of Changes
Other Study ID Numbers: Phytos QLRT-2000-00431-WP3
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: October 2002

Keywords provided by TNO:
early menopause
bone metabolism
bone mineral density

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs