MedTrace Logo

Cacao Consumption in Patients With Insulin Resistance

NCT03034291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2017-01-30

No results posted yet for this study

Summary

Metabolic syndrome (MS) is a clinical entity that includes several disorders that predispose to imbalance in lipid metabolism: hypertension, insulin resistance, hypertriglyceridemia, obesity and low levels of high density lipoprotein. The SM itself has a great impact on morbidity and mortality and is also related to increased cerebrovascular risk and Diabetes Mellitus 2 (DM2). In Colombia, DM2 is one of the 10 leading causes of illness and death in people over 45 years. It is accepted that insulin resistance is a stage that precedes the onset of DM2, but there are few alternatives to reverse it or prevent its progression to diabetes.

The control of insulin resistance requires increased physical activity, reduced body weight and changes in eating patterns, measures that are not easily adopted in modern Western society.

There is evidence of the effect of chocolate consumption on increasing insulin sensitivity in both hypertensive diabetic patients as well as in normal individuals, apparently because of the ability of cocoa polyphenols to increase the bioavailability of nitric oxide, Formation of reactive species of oxine, optimizing carbohydrate metabolism and modulating insulin-related cellular signaling events.

A prospective, double-blind, placebo-controlled, double-blind clinical trial evaluating the effect of 50 g of chocolate with 70% cocoa solids, which contributes at least 430 mg of polyphenols, is conducted for 8 weeks in The reduction of insulin resistance defined by the reduction of the HOMA-IR index. In addition, there was an increase in arterial reactivity in non-diabetic individuals with central obesity and insulin resistance. Likewise, to infer the effect of this food intervention in the modification of the total cardiometabolic risk of the participants.

Conditions

Interventions

DIETARY_SUPPLEMENT

Cacao 70%

Consumption for 8 weeks of 50 grams of chocolate per day with 70% cocoa solids.

DIETARY_SUPPLEMENT

White chocolate

Sponsors & Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Universidad de Antioquia

    lead OTHER

Principal Investigators

  • Mónica L Giraldo, PhD · Universidad de Antioquia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-12-31
Completion
2014-03-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034291 on ClinicalTrials.gov