Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

NCT01886989 | Completed DMC

• 1 other identifier: HE-12-52
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; cocoa polyphenols; postprandial glycemia; postprandial lipemia

Outcome Measures

Primary Outcomes (1)

• Blood pressure (mm Hg)

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

  2.5 years

Secondary Outcomes (3)

• Glucose (mg/dL)

  2.5 years

• Blood lipids

  2.5 years

• Inflammation

  2.5 years

Study Arms (2)

Cocoa

EXPERIMENTAL

Cocoa polyphenols (960mg)

Dietary Supplement: Cocoa polyphenols

Placebo

PLACEBO COMPARATOR

Placebo powder (109mg polyphenols) in water

Dietary Supplement: Cocoa polyphenols

Interventions

Cocoa polyphenols DIETARY_SUPPLEMENT

Cocoa polyphenols (960mg) reconstituted in water

Cocoa; Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of type 2diabetes

You may not qualify if:

• on insulin therapy

Sponsors & Collaborators

• Arpita Basu: lead

Study Sites (1)

Department of Nutritional Sciences

Stillwater, Oklahoma, 74078, United States

Location

Related Publications (2)

• Davis DW, Tallent R, Navalta JW, Salazar A, Lyons TJ, Basu A. Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal. Nutrients. 2020 Jun 27;12(7):1902. doi: 10.3390/nu12071902.

  PMID: 32605005 DERIVED

• Basu A, Betts NM, Leyva MJ, Fu D, Aston CE, Lyons TJ. Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat Breakfast. J Nutr. 2015 Oct;145(10):2325-32. doi: 10.3945/jn.115.215772. Epub 2015 Sep 2.

  PMID: 26338890 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• ARPITA BASU, PHD

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)