Clinical trial NCT01496235: Effect of Cocoa Consumption in Cardiovascular and Immune Parameters
Official title: Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arterial Hypertension
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in diastolic blood pressure
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in systolic blood pressure
timeFrame: Baseline and 12 weeks
measure: Change in total cholesterol
timeFrame: Baseline and 12 weeks
measure: Change in low density lipoprotein cholesterol
timeFrame: Baseline and 12 weeks
measure: Change in high density lipoprotein cholesterol
timeFrame: Baseline and 12 weeks
measure: Change in triglycerides levels
timeFrame: Baseline and 12 weeks
measure: Change in hs-CRP
timeFrame: Baseline and 12 weeks
measure: Change in IL-1 beta levels
timeFrame: Baseline and 12 weeks
measure: Change in IL-2 levels
timeFrame: Baseline and 12 weeks
measure: Change in tumor necrosis factor alpha levels
timeFrame: Baseline and 12 weeks
measure: Change in flow mediated dilatation of the brachial artery
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Sede Investigaciones Universitarias, Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Monica L Giraldo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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