Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Not Applicable

Terminated

• Conditions: Arterial Hypertension
• Interventions: Dietary Supplement: Dark chocolate; Dietary Supplement: White chocolate

• Registration Number: NCT01496235
• Lead Sponsor: Universidad de Antioquia

Brief Summary

Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase nitric oxide production and is involved in controlling blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2011-11-24
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-16
• Last Update Submitted: 2011-12-16
• Study First Posted: 2011-12-21
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Age: 18 - 65 years old
• Resides in Medellín City
• Attached from the contributive regimen of Colombian Health System
• Essential Arterial Hypertension, stage I. Diagnosis less than 3 months.
• Medically indicated non-pharmacological therapy.
• Voluntary desire to consume 50 grams of chocolate per day for 12 weeks.
• Voluntary desire to participate in the trial and sign informed consent.

Exclusion Criteria

• Suspect of secondary hypertension
• Suspect of injury in target organ
• Presence of diabetes mellitus
• BMI (Body Mass Index) major or equal to 30
• Present smoker or with less than four weeks of abstinence of tobacco
• Consume antiplatelet substances
• Regular consumption of antioxidants, multivitamins, anti-inflammatory medications, drugs for nasal congestion and sibutramine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dark chocolate	Dark chocolate	Presence of 70% cocoa solids
White chocolate	White chocolate	-

Primary Outcome Measures

Name	Time	Method
Change in diastolic blood pressure	Baseline and 12 weeks	Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	Baseline and 12 weeks	Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
Change in total cholesterol	Baseline and 12 weeks
Change in low density lipoprotein cholesterol	Baseline and 12 weeks
Change in high density lipoprotein cholesterol	Baseline and 12 weeks
Change in triglycerides levels	Baseline and 12 weeks
Change in hs-CRP	Baseline and 12 weeks
Change in IL-1 beta levels	Baseline and 12 weeks
Change in IL-2 levels	Baseline and 12 weeks
Change in tumor necrosis factor alpha levels	Baseline and 12 weeks
Change in flow mediated dilatation of the brachial artery	Baseline and 12 weeks

Trial Locations

Locations (1)

Sede Investigaciones Universitarias, Universidad de Antioquia; 🇨🇴 Medellín, Antioquia, Colombia