Effect of Cocoa Consumption in Cardiovascular and Immune Parameters
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ClinicalTrials.gov Identifier: NCT01496235 |
Recruitment Status :
Terminated
(Difficulties with the patient recruitment)
First Posted : December 21, 2011
Last Update Posted : December 21, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arterial Hypertension | Dietary Supplement: Dark chocolate Dietary Supplement: White chocolate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | July 2009 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Dark chocolate
Presence of 70% cocoa solids
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Dietary Supplement: Dark chocolate
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 |
Placebo Comparator: White chocolate |
Dietary Supplement: White chocolate
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 |
- Change in diastolic blood pressure [ Time Frame: Baseline and 12 weeks ]Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
- Change in systolic blood pressure [ Time Frame: Baseline and 12 weeks ]Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
- Change in total cholesterol [ Time Frame: Baseline and 12 weeks ]
- Change in low density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ]
- Change in high density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ]
- Change in triglycerides levels [ Time Frame: Baseline and 12 weeks ]
- Change in hs-CRP [ Time Frame: Baseline and 12 weeks ]
- Change in IL-1 beta levels [ Time Frame: Baseline and 12 weeks ]
- Change in IL-2 levels [ Time Frame: Baseline and 12 weeks ]
- Change in tumor necrosis factor alpha levels [ Time Frame: Baseline and 12 weeks ]
- Change in flow mediated dilatation of the brachial artery [ Time Frame: Baseline and 12 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496235
Colombia | |
Sede Investigaciones Universitarias, Universidad de Antioquia | |
Medellín, Antioquia, Colombia |
Principal Investigator: | Monica L Giraldo, PhD | Universidad de Antioquia |
Responsible Party: | Monica Lucia Giraldo, Principal Investigator, Universidad de Antioquia |
ClinicalTrials.gov Identifier: | NCT01496235 |
Other Study ID Numbers: |
Cacao I |
First Posted: | December 21, 2011 Key Record Dates |
Last Update Posted: | December 21, 2011 |
Last Verified: | December 2011 |
Hypertension Vascular Diseases Cardiovascular Diseases |