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

This study is ongoing, but not recruiting participants.

First Received: May 12, 2008 Last Updated: November 9, 2009 History of Changes

Sponsor:	University of East Anglia
Collaborators:	Institute of Food Research The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK) Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) Diabetes UK Frutarom Netherlands B.V. - Soy producer Barry Callebaut - chocolate manufacturer contracted to produce intervention foods
Information provided by:	University of East Anglia
ClinicalTrials.gov Identifier:	NCT00677599

Purpose

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.

Condition	Intervention
Cardiovascular Disease Diabetes	Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by University of East Anglia:

Primary Outcome Measures:

Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples . [ Time Frame: 6 months - 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention A: Active Comparator Experimental arm enriched with flavonoids	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.
Intervention B: Placebo Comparator	Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds) 27g placebo chocolate bar to be consumed for 365 days.

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Female
Having had a natural menopause and a minimum of 1 year since last menstruation
Caucasian
under 70 years
Type 2 diabetics
Those using statins (≥40 mg simvastatin or ≥10 mg atorvastatin) for at least 12 months
Not currently taking Hormone Replacement Therapy (HRT) and not having taken HRT for a minimum of 6 months prior to commencement
Having no significant past or present medical history of vascular disease, or cancers (specifically breast, uterine or ovarian)
Never-smokers, and ex-smokers who have given up smoking at least 12 months before recruitment to the study

Exclusion Criteria

Currently taking HRT or having taken this medication within 6 months of the trial
Those prescribed to use statin therapy for less than 12 months Significant past or present medical history of vascular disease (including ECG and enzyme confirmed myocardial infarction, clinical angina, ischaemic stroke peripheral vascular disease, intermittent claudication) or cancer (especially breast, uterine or ovarian)
Hypertensive's with a systolic BP ≥ 160 mm Hg at maximum, or hypertensive's with a systolic BP ≤160 mm Hg at maximum, but who have received antihypertensive therapy for less than 12 months or have had increases to their medication indicating poor control
Current smokers or those having given up smoking less than 12 months before recruitment to the study
Those prescribed aspirin for a period of less than 12 months prior to recruitment
Those prescribed insulin for a period of less than 12 months prior to recruitment and those having had increases to their medication indicating poor control
Regular non-prescribed use of anti-inflammatory pain relief medication (i.e. aspirin, paracetamol, cocodamol).
Taking other counter indicative medication e.g. steroidal medication during the trial, or within 1 month of the trial beginning.
Taking food / dietary supplements e.g. vitamins, minerals, fish oils, plant oils, isoflavones, soy products, carotenoids during the trial (unless prepared to cease intake during, and 1 month preceding the trial).
Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
Assessed from the clinical screening: HbA1c ≥ 10%; Creatinine >125µmol/L; ALP > 378 IU/L; ALT >150 IU/L; GGT > 180 IU/L

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677599

Locations

United Kingdom, Norfolk
University of East Anglia (UK); School of Medicine, Health Policy and Practice
Norwich, Norfolk, United Kingdom, NR47TJ

Sponsors and Collaborators

University of East Anglia

Institute of Food Research

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

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

Diabetes UK

Frutarom Netherlands B.V. - Soy producer

Barry Callebaut - chocolate manufacturer contracted to produce intervention foods

Investigators

Principal Investigator:

Aedin MM Cassidy, PhD

University of East Anglia

More Information

No publications provided

Responsible Party:	School of Medicine, Health Policy & Practice, University of East Anglia ( Aedin Cassidy; Professor of Nutrition )
Study ID Numbers:	R15098, REC Ref: 07/H0310/136
Study First Received:	May 12, 2008
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00677599 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of East Anglia:

Cardiovascular disease
type 2 diabetes
flavonoids
cocoa
soy

epicatechin
postmenopausal
carotid intima media thickness
plaque volume

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010