Trial | NCT01463436  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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.
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.
Study Started
Jan 31
2010
Primary Completion
Mar 31
2010
Study Completion
Feb 28
2011
Last Update
Nov 02
2011
Estimate

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

  • Other names: kacang kedelai, soya bean

Dietary Supplement control group

the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months

  • Other names: plasebo

calcium carbonate 500 mg Placebo Comparator

The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months

soy isoflavone 100 mg Experimental

the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg

Criteria 

Inclusion Criteria:

healthy postmenopausal women
natural cessation 1-10 years
body mass index <=35 kg/m2
not receiving medication and supplement in the previous 6 months

Exclusion Criteria:

has chronic or terminal disease
severe psychosis
No Results Posted