Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Blood pressure (mm Hg)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of type 2diabetes
Exclusion Criteria
- •on insulin therapy
Arms & Interventions
Cocoa
Cocoa polyphenols (960mg)
Intervention: Cocoa polyphenols (Dietary Supplement)
Placebo
Placebo powder (109mg polyphenols) in water
Intervention: Cocoa polyphenols (Dietary Supplement)
Outcomes
Primary Outcomes
Blood pressure (mm Hg)
Time Frame: 2.5 years
Change in blood pressure and vascular function following cocoa and placebo intervention
Secondary Outcomes
- Blood lipids(2.5 years)
- Inflammation(2.5 years)
- Glucose (mg/dL)(2.5 years)
Investigators
Arpita Basu
Associate Professor
Oklahoma State University