Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

This study is currently recruiting participants.
Verified June 2013 by Oklahoma State University
Sponsor:
Information provided by (Responsible Party):
Oklahoma State University
ClinicalTrials.gov Identifier:
NCT01886989
First received: June 24, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Dietary Supplement: Cocoa polyphenols

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Oklahoma State University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cocoa
Cocoa polyphenols (960mg)
Dietary Supplement: Cocoa polyphenols
Cocoa polyphenols (960mg) reconstituted in water
Placebo Comparator: Placebo
Placebo powder (109mg polyphenols) in water

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of type 2diabetes

Exclusion Criteria:

  • on insulin therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886989

Contacts
Contact: ARPITA BASU, PHD 4057444437 arpita.basu@okstate.edu

Locations
United States, Oklahoma
Department of Nutritional Sciences Recruiting
Stillwater, Oklahoma, United States, 74078
Contact: ARPITA BASU, PHD    405-744-4437    arpita.basu@okstate.edu   
Principal Investigator: ARPITA BASU, PHD         
Sponsors and Collaborators
Oklahoma State University
Investigators
Principal Investigator: ARPITA BASU, PHD Oklahoma State University
  More Information

No publications provided

Responsible Party: Oklahoma State University
ClinicalTrials.gov Identifier: NCT01886989     History of Changes
Other Study ID Numbers: HE-12-52
Study First Received: June 24, 2013
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University:
diabetes
cocoa polyphenols
postprandial glycemia
postprandial lipemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014