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

This study has been completed.
Sponsor:
Collaborators:
Institute of Food Research
The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK)
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Diabetes UK
Frutarom Netherlands B.V. - Soy producer
Barry Callebaut - chocolate manufacturer contracted to produce intervention foods
Information provided by:
University of East Anglia
ClinicalTrials.gov Identifier:
NCT00677599
First received: May 12, 2008
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Diabetes
Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • 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 . [ Time Frame: 6 months - 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention A
Experimental arm enriched with flavonoids
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.
Other Name: Flavonoid enrichment of compounds found in cocoa and soy versus placebo control
Placebo Comparator: Intervention B Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)
27g placebo chocolate bar to be consumed for 365 days.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677599

Locations
United Kingdom
University of East Anglia (UK); School of Medicine, Health Policy and Practice
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Institute of Food Research
The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK)
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Diabetes UK
Frutarom Netherlands B.V. - Soy producer
Barry Callebaut - chocolate manufacturer contracted to produce intervention foods
Investigators
Principal Investigator: Aedin MM Cassidy, PhD University of East Anglia
  More Information

No publications provided by University of East Anglia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aedin Cassidy; Professor of Nutrition, School of Medicine, Health Policy & Practice, University of East Anglia
ClinicalTrials.gov Identifier: NCT00677599     History of Changes
Other Study ID Numbers: R15098, REC Ref: 07/H0310/136
Study First Received: May 12, 2008
Last Updated: May 12, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of East Anglia:
Cardiovascular disease
type 2 diabetes
flavonoids
cocoa
soy
epicatechin
postmenopausal
carotid intima media thickness
plaque volume

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014