Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Cocoa polyphenols

• Registration Number: NCT01886989
• Lead Sponsor: Arpita Basu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-26
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• clinical diagnosis of type 2diabetes

Exclusion Criteria

• on insulin therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Cocoa polyphenols	Placebo powder (109mg polyphenols) in water
Cocoa	Cocoa polyphenols	Cocoa polyphenols (960mg)

Primary Outcome Measures

Name	Time	Method
Blood pressure (mm Hg)	2.5 years	Change in blood pressure and vascular function following cocoa and placebo intervention

Secondary Outcome Measures

Name	Time	Method
Blood lipids	2.5 years	Change in lipids and lipoprotein levels at fasting, 30min, 1, 2, 4, \& 6 hours postprandial following cocoa
Inflammation	2.5 years	Change in CRP and interleukins levels at fasting, 30min, 1, 2, 4, \& 6 hours postprandial following cocoa
Glucose (mg/dL)	2.5 years	Change in glucose levels at fasting, 30min, 1, 2, 4, \& 6 hours postprandial following cocoa and placebo intervention

Trial Locations

Locations (1)

Department of Nutritional Sciences; 🇺🇸 Stillwater, Oklahoma, United States