NCT00301353

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: TNO · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Isoflavones-enriched foods

Timeline

• Start date: 2002-10-01
• Completion: 2004-07-01
• First posted: 2006-03-10
• Last updated: 2015-05-21

Locations

3 sites across 3 countries: France, Italy, Netherlands