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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
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.
Age
47 - 60 years
Sex
FEMALE
Healthy Volunteers
Yes
Trisakti University
Jakarta, DKI Jakarta, Indonesia
Start Date
January 1, 2010
Primary Completion Date
March 1, 2010
Completion Date
February 1, 2011
Last Updated
November 2, 2011
200
ACTUAL participants
soy isoflavone
DIETARY_SUPPLEMENT
control group
DIETARY_SUPPLEMENT
Lead Sponsor
Trisakti University
NCT07241390
NCT03372733
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06909773