Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330096
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2006-05-24
Brief Title:
Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties These compounds may be partially responsible for some of the positive links found between fruits and vegetables intake and higher bone mineral density in adults and children Several animal studies have shown that consumption of onions which are rich in quercetin rutin a quercetin glycoside and resvatrol found in red wine inhibits ovariectomy induced bone loss in rats One of the most studied flavonoids with respect to bone health is the soy isoflavones However consumption of soy products is relatively low in Western countries One the other hand a flavonoid such as hesperidin found mostly in oranges is much more abundant in the Western diet Citrus juice consumption has been demonstrated to prevent bone loss in male orchidectomized rats while specifically feeding hesperidin has been shown to prevent bone loss in ovariectomized mice and rats However to date no clinical prove has been obtained for these benefitsTherefore the aim of this study is to investigate the effect of hesperidin in preventing bone loss in postmenopausal women This study is designed as a 2-year double blind placebo-controlled two arm and parallel group study The primary outcome measure is change in bone mineral density BMD while the secondary outcome measures are changes in bone resorption and formation markers as well as body composition The women are randomised to consume 2 servings of hesperidin-rich food or food without hesperidin but with the same taste appearance placebo Subjects will undergo medical screening anthropometry physical activity dietary assessments and BMD before randomisation into placebo or active group Follow-up measurements are made at 3-month intervals for blood and urine collection and 6-month intervals for bone mineral density Side effects are also being monitored during each visit
Detailed Description:
None
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