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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Disease, Diabetes

Intervention / Treatment
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* Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)
* Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention A<br>Experimental arm enriched with flavonoids | Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)<br>* 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.<br>* Other names: Flavonoid enrichment of compounds found in cocoa and soy versus placebo control;|
| Placebo Comparator: Intervention B<br> | Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)<br>* 27g placebo chocolate bar to be consumed for 365 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavonoids, Cardiovascular disease, type 2 diabetes, cocoa, soy, epicatechin, postmenopausal, carotid intima media thickness, plaque volume