Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301353
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2006-03-03
Brief Title:
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Sponsor:
TNO
Organization:
TNO
Study Overview
Official Title:
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None