Cacao Consumption in Patients With Insulin Resistance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03034291|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 30, 2017
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Changes in the insulin resistance index (HOMA-IR) [ Time Frame: Baseline and 8 weeks ]Changes HOMA-IR
- Anthropometric measurement 1 [ Time Frame: 8 weeks ]Body weight (kilograms)
- Anthropometric measurement 2 [ Time Frame: 8 weeks ]body mass index
- Anthropometric measurement 3 [ Time Frame: 8 weeks ]abdominal waist (centimeters)
- SF-36 Questionnaire of Quality of life [ Time Frame: 8 weeks ]Improvement in the quality of life
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
|Principal Investigator:||Mónica L Giraldo, PhD||Universidad de Antioquia|