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Sponsors and Collaborators: |
TNO Quality of Life European Commission National Institute for Research on Food and Nutrition Institute National de la Recherche Agronomique |
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Information provided by: | TNO Quality of Life |
ClinicalTrials.gov Identifier: | NCT00301353 |
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 |
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Osteoporosis |
Drug: Isoflavones-enriched foods |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Phytoestrogen-Rich Diets on Bone Turnover in Postmenopausal Women |
Estimated Enrollment: | 300 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | July 2004 |
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.
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy as assessed by the:
Postmenopausal (≥12 - ≤60 months since last menses), determined by
Exclusion Criteria:
Osteoporosis, determined by
Having a history of medical or surgical events that may significantly affect the study outcome, including:
Use of concomitant medication including
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 |
Principal Investigator: | Elizabeth Brink, PhD | TNO Quality of Life |
Study ID Numbers: | Phytos QLRT-2000-00431-WP3 |
Study First Received: | March 3, 2006 |
Last Updated: | March 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00301353 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
early menopause isoflavones/phyto-estrogens bone metabolism bone mineral density hormones |
Musculoskeletal Diseases Menopause, Premature Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Menopause |