NCT01463436

The Effect of Soy Isoflavone Supplementation on Endothelial Function

Study of Soy Isoflavone 100 mg/Day in Postmenopausal Women to Elaborate the Effect of Soy Isoflavone in Endothelial Function and to Reduce Oxidative Stress

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Trisakti University · Academic / Other
• Sex: Female
• Age: 47 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A randomized double blind controlled trial was conducted to evaluate the effect of daily supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged 47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial function.

Detailed description

The subject were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavone and calcium carbonate 500 mg and the control group receiving 500 mg calcium carbonate for 1 year. This study was carried out 13 months(13 x 28 days). There were three outcome measure from this study; vascular cell adhesion molecule-(VCAM-1), nitric oxide (NO) and malonyldialdehyde (MDA). The outcome measure will be assessed at three times; before soy isoflavone supplementation / the beginning of study,post supplementation 6 months and 12 months. The outcome will be measured change from baseline in the level of VCAM-1, NO and MDA.

Conditions

• Cardiovascular Disease
• Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	soy isoflavone	100 mg soy isoflavone tablet containing genistein 55%, daidzein 39% and glycitein 6% and calcium carbonate 500 mg in the experimental group for 6 months and 12 months
DIETARY_SUPPLEMENT	control group	the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-03-01
• Completion: 2011-02-01
• First posted: 2011-11-01
• Last updated: 2011-11-02

Locations

1 site across 1 country: Indonesia