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The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors

Primary Purpose

Diabetes, Cardiovascular Risk

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
soy protein
isoflavones
milk protein
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Diabetes

Eligibility Criteria

46 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes

Exclusion Criteria:

  • Women with breast, ovary or other cancers in recent 5-year
  • Severe renal or liver dysfunction
  • Women with androgen excess
  • Smokers
  • Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    soy protein and isoflavones

    milk protein and isoflavones

    milk protein only

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 5, 2009
    Last Updated
    March 5, 2009
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00856882
    Brief Title
    The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors
    Official Title
    The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Cardiovascular Risk

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    soy protein and isoflavones
    Arm Type
    Experimental
    Arm Title
    milk protein and isoflavones
    Arm Type
    Experimental
    Arm Title
    milk protein only
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    soy protein
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    isoflavones
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    milk protein

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    46 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes Exclusion Criteria: Women with breast, ovary or other cancers in recent 5-year Severe renal or liver dysfunction Women with androgen excess Smokers Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24659208
    Citation
    Liu ZM, Ho CS, Chen YM, Woo J. Can soy intake affect serum uric acid level? Pooled analysis from two 6-month randomized controlled trials among Chinese postmenopausal women with prediabetes or prehypertension. Eur J Nutr. 2015 Feb;54(1):51-8. doi: 10.1007/s00394-014-0684-1.
    Results Reference
    derived
    PubMed Identifier
    19918248
    Citation
    Liu ZM, Ho SC, Chen YM, Ho YP. A mild favorable effect of soy protein with isoflavones on body composition--a 6-month double-blind randomized placebo-controlled trial among Chinese postmenopausal women. Int J Obes (Lond). 2010 Feb;34(2):309-18. doi: 10.1038/ijo.2009.236. Epub 2009 Nov 17.
    Results Reference
    derived

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    The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors

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