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This study aims to investigate the postprandial effects of cocoa supplementation in glucose and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in patients with diabetes. Randomized cross-over controlled trial, in which participants will be assigned to the placebo or cocoa group with breakfast meal. Patients with type 2 diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI) measurements will be conducted at fasting, 30 min, 1,2, 4 & 6 hours postprandial each day for 2 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocoa | Experimental | Cocoa polyphenols (960mg) |
|
| Placebo | Placebo Comparator | Placebo powder (109mg polyphenols) in water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa polyphenols | Dietary Supplement | Cocoa polyphenols (960mg) reconstituted in water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure (mm Hg) | Change in blood pressure and vascular function following cocoa and placebo intervention | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose (mg/dL) | Change in glucose levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa and placebo intervention | 2.5 years |
| Blood lipids | Change in lipids and lipoprotein levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ARPITA BASU, PHD | Oklahoma State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutritional Sciences | Stillwater | Oklahoma | 74078 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32605005 | Derived | Davis DW, Tallent R, Navalta JW, Salazar A, Lyons TJ, Basu A. Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal. Nutrients. 2020 Jun 27;12(7):1902. doi: 10.3390/nu12071902. | |
| 26338890 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 2.5 years |
| Inflammation | Change in CRP and interleukins levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa | 2.5 years |
| Basu A, Betts NM, Leyva MJ, Fu D, Aston CE, Lyons TJ. Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat Breakfast. J Nutr. 2015 Oct;145(10):2325-32. doi: 10.3945/jn.115.215772. Epub 2015 Sep 2. |