The Effect of Soy Isoflavone Supplementation on Endothelial Function

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463436
• Other study ID #: Usakti
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2011
• Last updated: November 1, 2011
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Trisakti University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 47 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Indonesia	Trisakti University	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Trisakti University

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	13 months	Yes
Secondary	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	6 months	Yes

External Links

•   click here for more information about this tudy