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The Effect of Soy Isoflavone Supplementation on Endothelial Function

NCT ID: NCT01463436

Last Updated: 2011-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-02-28

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.

Conditions

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Cardiovascular Disease Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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soy isoflavone 100 mg

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

Group Type EXPERIMENTAL

soy isoflavone

Intervention Type 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

calcium carbonate 500 mg

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

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

control group

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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kacang kedelai, soya bean plasebo

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
Minimum Eligible Age

47 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Trisakti University

OTHER

Sponsor Role lead

Responsible Party

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Dr. dr. Pusparini SpPK

Principal investigator, staff of Clinical Pathology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pusparini Sunarno, Doctor

Role: PRINCIPAL_INVESTIGATOR

Trisakti University

Locations

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Trisakti University

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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Hall WL, Rimbach G, Williams CM. isoflavones and endothelial function. Nutrion Research Review 18:123-131, 2005. Vincent A,Fitzpatrick LA. soy Isoflavone: are they useful in menopause? Mayo clinic Proceeding 75:1171-1184, 2000

Reference Type BACKGROUND

Related Links

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http://www.univmed.org

click here for more information about this tudy

Other Identifiers

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Usakti

Identifier Type: -

Identifier Source: org_study_id