- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00677599
The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes (FLAVO)
May 12, 2011 updated by: University of East Anglia
Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom, NR47TJ
- University of East Anglia (UK); School of Medicine, Health Policy and Practice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intervention A
Experimental arm enriched with flavonoids
|
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 Names:
27g placebo chocolate bar to be consumed for 365 days.
|
PLACEBO_COMPARATOR: Intervention B
|
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 Names:
27g placebo chocolate bar to be consumed for 365 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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 .
Time Frame: 6 months - 1 year
|
6 months - 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aedin MM Cassidy, PhD, University of East Anglia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
April 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
May 12, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (ESTIMATE)
May 14, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 13, 2011
Last Update Submitted That Met QC Criteria
May 12, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R15098
- REC Ref: 07/H0310/136
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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