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NCT Number: NCT01463436

The Effect of Soy Isoflavone Supplementation on Endothelial Function

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.

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Key information

Conditions

Cardiovascular Disease Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

47 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Trisakti University

Jakarta, DKI Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soy isoflavone

Dietary 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

Other names: kacang kedelai, soya bean

Control group

Dietary Supplement

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

Other names: plasebo

Primary outcomes

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

    Time frame: 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 outcomes

  1. the changes levels of osteoporosis parameter after 6 months supplementation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Trisakti University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 1, 2011
Registry last updated
Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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