Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886989
• Other study ID #: HE-12-52
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: January 18, 2018
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of type 2diabetes

Exclusion Criteria:

• on insulin therapy

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Cocoa polyphenols
Cocoa polyphenols (960mg) reconstituted in water

Locations

Country	Name	City	State
United States	Department of Nutritional Sciences	Stillwater	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Arpita Basu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure (mm Hg)	Change in blood pressure and vascular function following cocoa and placebo intervention	2.5 years
Secondary	Glucose (mg/dL)	Change in glucose levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa and placebo intervention	2.5 years
Secondary	Blood lipids	Change in lipids and lipoprotein levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa	2.5 years
Secondary	Inflammation	Change in CRP and interleukins levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa	2.5 years