NCT03034291

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

January 23, 2017

Last Update Submit

January 27, 2017

Conditions

Insulin Resistance

Keywords

CocoaobesityHOMA-IRBMIQuality of life

Outcome Measures

Primary Outcomes (1)

  • Changes in the insulin resistance index (HOMA-IR)

    Changes HOMA-IR

    Baseline and 8 weeks

Secondary Outcomes (4)

  • Anthropometric measurement 1

    8 weeks

  • Anthropometric measurement 2

    8 weeks

  • Anthropometric measurement 3

    8 weeks

  • SF-36 Questionnaire of Quality of life

    8 weeks

Study Arms (2)

Cacao 70%

EXPERIMENTAL

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%

White chocolate

PLACEBO COMPARATOR

Consumption for eight weeks of 50 grams of chocolate free of cocoa solids as placebo.

Dietary Supplement: White chocolate

Interventions

Cacao 70%DIETARY_SUPPLEMENT

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

Cacao 70%
White chocolateDIETARY_SUPPLEMENT
White chocolate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mónica L Giraldo, PhD

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 27, 2017

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share