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Completed

NCT Number: NCT01886989

Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Sciences

Stillwater, Oklahoma, 74078, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of type 2diabetes

Exclusion criteria

  • on insulin therapy

Treatment and study plan

cocoa polyphenols

Dietary Supplement

Cocoa polyphenols (960mg) reconstituted in water

Primary outcomes

  1. Blood pressure (mm Hg)

    Time frame: 2.5 years

    Change in blood pressure and vascular function following cocoa and placebo intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Arpita Basu

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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