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Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oklahoma State University
ClinicalTrials.gov Identifier:
NCT01886989
First received: June 24, 2013
Last updated: December 22, 2014
Last verified: December 2014

June 24, 2013
December 22, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
Blood pressure (mm Hg) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Change in blood pressure and vascular function following cocoa and placebo intervention
Same as current
Complete list of historical versions of study NCT01886989 on ClinicalTrials.gov Archive Site
Glucose (mg/dL) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Change in glucose levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa and placebo intervention
Same as current
Not Provided
Not Provided
 
Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes
Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Type 2 Diabetes
Dietary Supplement: Cocoa polyphenols
Cocoa polyphenols (960mg) reconstituted in water
  • Experimental: Cocoa
    Cocoa polyphenols (960mg)
    Intervention: Dietary Supplement: Cocoa polyphenols
  • Placebo Comparator: Placebo
    Placebo powder (109mg polyphenols) in water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of type 2diabetes

Exclusion Criteria:

  • on insulin therapy
Both
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01886989
HE-12-52
Yes
Oklahoma State University
Oklahoma State University
Not Provided
Principal Investigator: ARPITA BASU, PHD Oklahoma State University
Oklahoma State University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP