The Effect of Soy Isoflavone Supplementation on Endothelial Function

Trisakti University200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Cardiovascular Disease Osteoporosis

Interventions

soy isoflavoneDIETARY_SUPPLEMENT

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

control groupDIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 47 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Trisakti University

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

the changes levels of endothelial function marker in blood after 13 months supplementation

this study were measured the change levels of vascular cell adhesion molecule-1 (VCAM-1), nitric oxide (NO) as endothelial function parameter and malonyldialdehide as lipid peroxidation parameter from baseline to 6 months supplementation and from baseline to 13 months supplementation

Time frame: 13 months

Secondary Outcomes

the changes levels of osteoporosis parameter after 6 months supplementation

This study have another outcome such as rank ligand, C telopeptide and osteoprotegrin as marker of osteoporosis. We will be measured the changes levels of osteoporosis marker after 6 months supplementation

Time frame: 6 months

Data from ClinicalTrials.gov

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