Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Cocoa polyphenols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of type 2diabetes Exclusion Criteria: on insulin therapy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocoa<br>Cocoa polyphenols (960mg) | Dietary Supplement: Cocoa polyphenols<br>* Cocoa polyphenols (960mg) reconstituted in water<br>|
| Placebo Comparator: Placebo<br>Placebo powder (109mg polyphenols) in water | Dietary Supplement: Cocoa polyphenols<br>* Cocoa polyphenols (960mg) reconstituted in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (mm Hg) | Change in blood pressure and vascular function following cocoa and placebo intervention | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2.5 years | 
| Inflammation | Change in CRP and interleukins levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, cocoa polyphenols, postprandial glycemia, postprandial lipemia