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| ID | Type | Description | Link |
|---|---|---|---|
| REC Ref: 07/H0310/136 |
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| Name | Class |
|---|---|
| Quadram Institute Bioscience | OTHER |
| The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK) | UNKNOWN |
| Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention A | Active Comparator | Experimental arm enriched with flavonoids |
|
| Intervention B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavonoid enrichment (cocoa / soy compounds) | 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. |
| Measure | Description | 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 . | 6 months - 1 year |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Aedin MM Cassidy, PhD | University of East Anglia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of East Anglia (UK); School of Medicine, Health Policy and Practice | Norwich | Norfolk | NR47TJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23553151 | Derived | 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. | |
| 22250063 |
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| Diabetes UK | OTHER |
| Frutarom Netherlands B.V. - Soy producer | UNKNOWN |
| Barry Callebaut - chocolate manufacturer contracted to produce intervention foods | UNKNOWN |
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| Flavonoid enrichment (cocoa / soy compounds) | Dietary Supplement | 27g placebo chocolate bar to be consumed for 365 days. |
|
| 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. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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