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NCT00457262 Clinical Trial

Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women

Hyperlipidemia Clinical Trial

Official title:
Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00457262
Other study ID # 1344
Secondary ID
Status Completed
Phase N/A
First received April 4, 2007
Last updated April 4, 2007
Start date January 2006
Est. completion date August 2006

Study information
Verified date March 2007
Source Iran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of paraoxonase1 activity and soy proteins may increase paraoxonase1 activity

Description:

In a double blind clinical randomised clinical trial with parallel design this study was done.52 postmenopausal women were randomly assigned to 50 g/d soy protein or placebo for 10 weeks.serum lipoproteins and pon1 activity were measured at baseline and 10th week.There were significant increase in PON! activity and significant decrease in LDL-C,LDL-C/HDL-C,TC/HDL-C and TG/HDL-C in soy group compare to placebo group.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 51 Years to 57 Years
Eligibility Inclusion Criteria:

- Cessation of menes for more than 1 year, elevation for more than 1 year

- Elevation of FSH level

- Total cholesterol

- Triglyceride more than 200 mg/dl

Exclusion Criteria:

- Chronic disease (heart disease, cancer, diabetes, hepatic, kidney and thyroid disease)

- Antihypertensive drugs

- Antibiotics

- Lipid lowering drugs

- Sex hormone treatment

- Hysterectomy

- Diet rich in soy protein

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• soy consumption

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Iran University of Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary decrease of LDL,increase of HDL,increase of paraoxonase 1
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