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

This study has been completed.
Sponsor:
Collaborators:
European Commission
National Institute for Research on Food and Nutrition
Institut National de la Recherche Agronomique
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00301353
First received: March 3, 2006
Last updated: March 8, 2006
Last verified: October 2002
  Purpose

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 Intervention
Osteoporosis
Drug: Isoflavones-enriched foods

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Phytoestrogen-Rich Diets on Bone Turnover in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by TNO:

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

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

Estimated Enrollment: 300
Study Start Date: October 2002
Estimated Study Completion Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301353

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

No publications provided by TNO

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00301353     History of Changes
Other Study ID Numbers: Phytos QLRT-2000-00431-WP3
Study First Received: March 3, 2006
Last Updated: March 8, 2006
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO:
early menopause
isoflavones/phyto-estrogens
bone metabolism
bone mineral density
hormones

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

ClinicalTrials.gov processed this record on September 18, 2014