The Effect of Soy Isoflavone Supplementation on Endothelial Function

November 1, 2011 updated by: Dr. dr. Pusparini SpPK, Trisakti University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • Trisakti University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: soy isoflavone 100 mg
the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg
Dietary supplement: soy isoflavone
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
Placebo Comparator: calcium carbonate 500 mg
The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months
Dietary supplement: control group
the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months
Other Names:
  • plasebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trisakti University

Investigators

  • Principal Investigator: Pusparini Sunarno, Doctor, Trisakti University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimate)

November 1, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Usakti

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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