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

Primary Purpose

Postmenopausal, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
soy consumption
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postmenopausal focused on measuring paraoxonase1 activity, LDL, HDL, postmenopausal women, postmenopausal women and hyperlipidemia

Eligibility Criteria

51 Years - 57 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    decrease of LDL,increase of HDL,increase of paraoxonase 1

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2007
    Last Updated
    April 4, 2007
    Sponsor
    Iran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00457262
    Brief Title
    Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
    Official Title
    Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Iran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postmenopausal, Hyperlipidemia
    Keywords
    paraoxonase1 activity, LDL, HDL, postmenopausal women, postmenopausal women and hyperlipidemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    42 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    soy consumption
    Primary Outcome Measure Information:
    Title
    decrease of LDL,increase of HDL,increase of paraoxonase 1

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    51 Years
    Maximum Age & Unit of Time
    57 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    farzad Shidfar, Ph.D
    Organizational Affiliation
    assistant professor of nutrition,Iran university of medical sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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