Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension

Conditions
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Arterial Hypertension

Intervention / Treatment
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* Dietary Supplement: Dark chocolate
* Dietary Supplement: White chocolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dark chocolate<br>Presence of 70% cocoa solids | Dietary Supplement: Dark chocolate<br>* Each chocolate bar provided 210 calories represented in 25 grams of carbohydrates, 3 g of proteins, 18 g of total fat and the presence of 70% cocoa solids<br>|
| Placebo Comparator: White chocolate<br> | Dietary Supplement: White chocolate<br>* Each chocolate bar provided 230 calories represented in 28 grams of carbohydrates, 3 g of proteins, 18 g of total fat, without the presence of 70% cocoa solids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diastolic blood pressure | Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure | Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring | Baseline and 12 weeks | 
| 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 |