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

Diabetes Clinical Trial

— FLAVO  

Official title:

Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677599
• Other study ID #: R15098
• Secondary ID: REC Ref: 07/H031
• Status: Completed
• Phase: N/A
• First received: May 12, 2008
• Last updated: May 12, 2011
• Start date: May 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2011
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Diabetes Mellitus, Type 2

Intervention

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.
• Flavonoid enrichment (cocoa / soy compounds)
27g placebo chocolate bar to be consumed for 365 days.

Locations

Country	Name	City	State
United Kingdom	University of East Anglia (UK); School of Medicine, Health Policy and Practice	Norwich	Norfolk

Sponsors (7)

Lead Sponsor	Collaborator
University of East Anglia	Barry Callebaut - chocolate manufacturer contracted to produce intervention foods, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Diabetes UK, Frutarom Netherlands B.V. - Soy producer, Institute of Food Research, The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .		6 months - 1 year	No