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The Effect of Soy Isoflavone Supplementation on Endothelial Function

Primary Purpose

Cardiovascular Disease, Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
soy isoflavone
control group
Sponsored by
Trisakti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring endothelial function, postmenopausal, soy isoflavone supplementation, osteoporosis

Eligibility Criteria

47 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Trisakti University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

soy isoflavone 100 mg

calcium carbonate 500 mg

Arm Description

the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg

The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2011
Last Updated
November 1, 2011
Sponsor
Trisakti University
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1. Study Identification

Unique Protocol Identification Number
NCT01463436
Brief Title
The Effect of Soy Isoflavone Supplementation on Endothelial Function
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trisakti University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Osteoporosis
Keywords
endothelial function, postmenopausal, soy isoflavone supplementation, osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
soy isoflavone 100 mg
Arm Type
Experimental
Arm Description
the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg
Arm Title
calcium carbonate 500 mg
Arm Type
Placebo Comparator
Arm Description
The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
soy isoflavone
Other Intervention Name(s)
kacang kedelai, soya bean
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
control group
Other Intervention Name(s)
plasebo
Intervention Description
the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months
Primary Outcome Measure Information:
Title
the changes levels of endothelial function marker in blood after 13 months supplementation
Description
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 Outcome Measure Information:
Title
the changes levels of osteoporosis parameter after 6 months supplementation
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pusparini Sunarno, Doctor
Organizational Affiliation
Trisakti University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trisakti University
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11075748
Citation
Vincent A, Fitzpatrick LA. Soy isoflavones: are they useful in menopause? Mayo Clin Proc. 2000 Nov;75(11):1174-84. doi: 10.4065/75.11.1174.
Results Reference
background
Links:
URL
http://www.univmed.org
Description
click here for more information about this tudy

Learn more about this trial

The Effect of Soy Isoflavone Supplementation on Endothelial Function

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