Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

NCT ID: NCT01886989

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cocoa

Cocoa polyphenols (960mg)

Group Type EXPERIMENTAL

Cocoa polyphenols

Intervention Type DIETARY_SUPPLEMENT

Cocoa polyphenols (960mg) reconstituted in water

Placebo

Placebo powder (109mg polyphenols) in water

Group Type PLACEBO_COMPARATOR

Cocoa polyphenols

Intervention Type DIETARY_SUPPLEMENT

Cocoa polyphenols (960mg) reconstituted in water

Interventions

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Cocoa polyphenols

Cocoa polyphenols (960mg) reconstituted in water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of type 2diabetes

Exclusion Criteria

* on insulin therapy
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arpita Basu

OTHER

Sponsor Role lead

Responsible Party

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Arpita Basu

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ARPITA BASU, PHD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

Locations

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Department of Nutritional Sciences

Stillwater, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32605005 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26338890 (View on PubMed)

Other Identifiers

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HE-12-52

Identifier Type: -

Identifier Source: org_study_id

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