The Effect of Soy Isoflavone Supplementation on Endothelial Function

Phase 3

Completed

• Conditions: Cardiovascular Disease; Osteoporosis
• Interventions: Dietary Supplement: soy isoflavone; Dietary Supplement: control group

• Registration Number: NCT01463436
• Lead Sponsor: Trisakti University

Brief 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-03
• Study Completion: 2011-02
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-31
• Status Verified: 2011-11
• Study First Posted: 2011-11-01
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
soy isoflavone 100 mg	soy isoflavone	the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg
calcium carbonate 500 mg	control group	The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the changes levels of osteoporosis parameter after 6 months supplementation	6 months	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

Trial Locations

Locations (1)

Trisakti University; 🇮🇩 Jakarta, DKI Jakarta, Indonesia