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Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01886989
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Arpita Basu, Oklahoma State University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Cocoa polyphenols Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cocoa
Cocoa polyphenols (960mg)
Dietary Supplement: Cocoa polyphenols
Cocoa polyphenols (960mg) reconstituted in water
Placebo Comparator: Placebo
Placebo powder (109mg polyphenols) in water
Dietary Supplement: Cocoa polyphenols
Cocoa polyphenols (960mg) reconstituted in water



Primary Outcome Measures :
  1. Blood pressure (mm Hg) [ Time Frame: 2.5 years ]
    Change in blood pressure and vascular function following cocoa and placebo intervention


Secondary Outcome Measures :
  1. Glucose (mg/dL) [ Time Frame: 2.5 years ]
    Change in glucose levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa and placebo intervention

  2. Blood lipids [ Time Frame: 2.5 years ]
    Change in lipids and lipoprotein levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa

  3. Inflammation [ Time Frame: 2.5 years ]
    Change in CRP and interleukins levels at fasting, 30min, 1, 2, 4, & 6 hours postprandial following cocoa



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of type 2diabetes

Exclusion Criteria:

  • on insulin therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886989


Locations
United States, Oklahoma
Department of Nutritional Sciences
Stillwater, Oklahoma, United States, 74078
Sponsors and Collaborators
Arpita Basu
Investigators
Principal Investigator: ARPITA BASU, PHD Oklahoma State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arpita Basu, Associate Professor, Oklahoma State University
ClinicalTrials.gov Identifier: NCT01886989     History of Changes
Other Study ID Numbers: HE-12-52
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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

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