The Effect of Soy Isoflavone Supplementation on Endothelial Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiovascular Disease, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: soy isoflavone
* Dietary Supplement: control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soy isoflavone 100 mg<br>the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg | Dietary Supplement: soy isoflavone<br>* 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<br>* Other names: kacang kedelai, soya bean;|
| Placebo Comparator: calcium carbonate 500 mg<br>The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months | Dietary Supplement: control group<br>* the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months<br>* Other names: plasebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, postmenopausal, soy isoflavone supplementation, osteoporosis