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The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes

NCT00677599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2011-05-13

No results posted yet for this study

Summary

The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.

Conditions

Interventions

DIETARY_SUPPLEMENT

Flavonoid enrichment (cocoa / soy compounds)

Flavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment.

DIETARY_SUPPLEMENT

Flavonoid enrichment (cocoa / soy compounds)

27g placebo chocolate bar to be consumed for 365 days.

Sponsors & Collaborators

  • Quadram Institute Bioscience

    collaborator OTHER

  • The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK)

    collaborator UNKNOWN

  • Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

    collaborator OTHER

  • Diabetes UK

    collaborator OTHER

  • Frutarom Netherlands B.V. - Soy producer

    collaborator UNKNOWN

  • Barry Callebaut - chocolate manufacturer contracted to produce intervention foods

    collaborator UNKNOWN

  • University of East Anglia

    lead OTHER

Principal Investigators

  • Aedin MM Cassidy, PhD · University of East Anglia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00677599 on ClinicalTrials.gov