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Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014