NCT00856882

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

March 5, 2009

Last Update Submit

March 5, 2009

Conditions

DiabetesCardiovascular Risk

Study Arms (3)

soy protein and isoflavones

EXPERIMENTAL
Dietary Supplement: soy proteinDietary Supplement: isoflavones

milk protein and isoflavones

EXPERIMENTAL
Dietary Supplement: isoflavonesDietary Supplement: milk protein

milk protein only

PLACEBO COMPARATOR
Dietary Supplement: milk protein

Interventions

soy proteinDIETARY_SUPPLEMENT
soy protein and isoflavones
isoflavonesDIETARY_SUPPLEMENT
milk protein and isoflavonessoy protein and isoflavones
milk proteinDIETARY_SUPPLEMENT
milk protein and isoflavonesmilk protein only

Eligibility Criteria

Age46 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24659208DERIVED

  • 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.

    PMID: 19918248DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Soybean ProteinsIsoflavonesMilk Proteins

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnimal Proteins, DietaryMilkDairy Products

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

October 1, 2007

Primary Completion

April 1, 2008

Last Updated

March 6, 2009

Record last verified: 2009-03