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Cacao Consumption in Patients With Insulin Resistance

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ClinicalTrials.gov Identifier: NCT03034291
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by (Responsible Party):
Universidad de Antioquia

Brief 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.


Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: Cacao 70% Dietary Supplement: White chocolate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Controlled Clinical Trial of the Effect of Cocoa Consumption in Patients With Insulin Resistance
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Cacao 70%
Consumption for eight weeks of 50 grams of chocolate with 70% cocoa solids equivalent to not less than 430 mg of cocoa polyphenols at each dose.
Dietary Supplement: Cacao 70%
Consumption for 8 weeks of 50 grams of chocolate per day with 70% cocoa solids.

Placebo Comparator: White chocolate
Consumption for eight weeks of 50 grams of chocolate free of cocoa solids as placebo.
Dietary Supplement: White chocolate



Primary Outcome Measures :
  1. Changes in the insulin resistance index (HOMA-IR) [ Time Frame: Baseline and 8 weeks ]
    Changes HOMA-IR


Secondary Outcome Measures :
  1. Anthropometric measurement 1 [ Time Frame: 8 weeks ]
    Body weight (kilograms)

  2. Anthropometric measurement 2 [ Time Frame: 8 weeks ]
    body mass index

  3. Anthropometric measurement 3 [ Time Frame: 8 weeks ]
    abdominal waist (centimeters)

  4. SF-36 Questionnaire of Quality of life [ Time Frame: 8 weeks ]
    Improvement in the quality of life



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Abdominal circumference greater than 80 cm in women and greater than 90 cm in men
  2. HOMA [basal insulin x basal glycemia] / 22.5 equal to or greater than 2.5
  3. Basal glycemia normal or compatible with carbohydrate intolerance (baseline glycemia less than 126 mg / dL).
  4. Disposition for the consumption of chocolate.
  5. Acceptance and signing of informed consent

Exclusion Criteria:

  1. Pregnancy
  2. Usual consumption of 50 g or more grams of chocolate three or more times per week
  3. Insulin application, consumption of metformin or any other hypoglycemic substance.
  4. Surgical history of gastric resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034291


Sponsors and Collaborators
Universidad de Antioquia
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
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Principal Investigator: Mónica L Giraldo, PhD Universidad de Antioquia

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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03034291     History of Changes
Other Study ID Numbers: Cacao IV
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad de Antioquia:
Cocoa
obesity
HOMA-IR
BMI
Quality of life

Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases