The Effect of Soy Isoflavone Supplementation on Endothelial Function

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01463436

Enrollment

200

Registered

2011-11-01

Start date

2010-01-31

Completion date

2011-02-28

Last updated

2011-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Osteoporosis

Keywords

endothelial function, postmenopausal, soy isoflavone supplementation, osteoporosis

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.

Interventions

DIETARY_SUPPLEMENTsoy 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

DIETARY_SUPPLEMENTcontrol group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

47 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026