Clinical trial NCT00677599: The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes
Official title: Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Diabetes
Keywords: Cardiovascular disease
type 2 diabetes
flavonoids
cocoa
soy
epicatechin
postmenopausal
carotid intima media thickness
plaque volume
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Quadram Institute Bioscience
name: The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK)
name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Diabetes UK
name: Frutarom Netherlands B.V. - Soy producer
name: Barry Callebaut - chocolate manufacturer contracted to produce intervention foods
First posted: 2008-05-14
Enrollment: 152
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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 .
timeFrame: 6 months - 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia (UK); School of Medicine, Health Policy and Practice
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Aedin MM Cassidy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curtis PJ, Potter J, Kroon PA, Wilson P, Dhatariya K, Sampson M, Cassidy A. Vascular function and atherosclerosis progression after 1 y of flavonoid intake in statin-treated postmenopausal women with type 2 diabetes: a double-blind randomized controlled trial. Am J Clin Nutr. 2013 May;97(5):936-42. doi: 10.3945/ajcn.112.043745. Epub 2013 Apr 3.
citation: Curtis PJ, Sampson M, Potter J, Dhatariya K, Kroon PA, Cassidy A. Chronic ingestion of flavan-3-ols and isoflavones improves insulin sensitivity and lipoprotein status and attenuates estimated 10-year CVD risk in medicated postmenopausal women with type 2 diabetes: a 1-year, double-blind, randomized, controlled trial. Diabetes Care. 2012 Feb;35(2):226-32. doi: 10.2337/dc11-1443. Epub 2012 Jan 16.