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Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes

A

Arpita Basu

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Dietary Supplement: Cocoa polyphenols

Study type

Interventional

Funder types

Other

Identifiers

NCT01886989
HE-12-52

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • clinical diagnosis of type 2diabetes

Exclusion criteria

  • on insulin therapy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

18 participants in 2 patient groups, including a placebo group

Cocoa
Experimental group
Description:
Cocoa polyphenols (960mg)
Treatment:
Dietary Supplement: Cocoa polyphenols
Placebo
Placebo Comparator group
Description:
Placebo powder (109mg polyphenols) in water
Treatment:
Dietary Supplement: Cocoa polyphenols

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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