Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Universidad de Antioquia

Status: Terminated

Conditions: Arterial Hypertension

Treatments: Dietary Supplement: White chocolate; Dietary Supplement: Dark chocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT01496235

Cacao I

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups, including a placebo group

Dark chocolate

Active Comparator group

Description:

Presence of 70% cocoa solids

Treatment:

Dietary Supplement: Dark chocolate

White chocolate

Placebo Comparator group

Treatment:

Dietary Supplement: White chocolate