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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 – trial funder Frutarom Netherlands B.V. – Soy producer Barry Callebaut – chocolate manufacturer contracted to produce intervention foods |
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Information provided by: | University of East Anglia |
ClinicalTrials.gov Identifier: | NCT00677599 |
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 |
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Cardiovascular Disease Diabetes |
Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes |
Estimated Enrollment: | 152 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intervention A: Active Comparator
Experimental arm enriched with flavonoids
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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.
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Intervention B: Placebo Comparator |
Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)
27g placebo chocolate bar to be consumed for 365 days.
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Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Peter J Curtis, PhD | 00441603 59 ext 1873 | P.curtis@uea.ac.uk |
Contact: Sarah C Edwards | 0044160359 ext 3746 | sarah.edwards@uea.ac.uk |
United Kingdom, Norfolk | |
University of East Anglia (UK); School of Medicine, Health Policy and Practice | Recruiting |
Norwich, Norfolk, United Kingdom, NR47TJ | |
Contact: Sarah C Edwards 01603 59 ext 3746 sarah.edwards@uea.ac.uk | |
Sub-Investigator: Peter J Curtis, PhD |
Principal Investigator: | Aedin MM Cassidy, PhD | University of East Anglia |
Responsible Party: | School of Medicine, Health Policy & Practice, University of East Anglia ( Aedin Cassidy; Professor of Nutrition ) |
Study ID Numbers: | R15098, REC Ref: 07/H0310/136 |
Study First Received: | May 12, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00677599 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
Cardiovascular disease type 2 diabetes flavonoids cocoa soy |
epicatechin postmenopausal carotid intima media thickness plaque volume |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Menopause |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Cardiovascular Diseases Glucose Metabolism Disorders |