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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-04-30

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.

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Detailed Description

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Conditions

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Cardiovascular Disease Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention A

Experimental arm enriched with flavonoids

Group Type ACTIVE_COMPARATOR

Flavonoid enrichment (cocoa / soy compounds)

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Flavonoid enrichment (cocoa / soy compounds)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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 Type DIETARY_SUPPLEMENT

Flavonoid enrichment (cocoa / soy compounds)

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Flavonoid enrichment of compounds found in cocoa and soy versus placebo control

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

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No