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

University of East Anglia

Status

Completed

Conditions

Diabetes

Cardiovascular Disease

Treatments

Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)

Study type

Interventional

Funder types

Other

Identifiers

NCT00677599

REC Ref: 07/H0310/136

R15098

Details and patient eligibility

About

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.

Enrollment

152 estimated patients

Sex

Female

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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