Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Universidad de Antioquia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by:
Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01276951
First received: May 24, 2010
Last updated: January 13, 2011
Last verified: May 2010
  Purpose

In Colombia, ischemic heart disease and stroke are one of the most important causes of death in 45 years old people. Care of cases of disease represents high costs for the health system in particular and society in general, due to the loss of productive years life and costs for the care of the aftermath. Hypertension (HT) is one of the preventable risk factors for major cerebrovascular disorders. The pathophysiology of Essential hypertension is complex and depends of interaction of genetic and environmental factors. Among the determining elements are the increase in the activity of the sympathetic nervous system, the vasoconstricting and overproduction of hormones associated with sodium retention, disruption in renin secretion with increased production of aldosterone and angiotensin II, the deregulation of the kinins system, the increase in peripheral vascular resistance and activity of Growth factors in atherogenesis and vascular endothelial dysfunction, increased cardiac output, diabetes mellitus, obesity, and lower production of vasodilators such as brain natriuretic peptide (BNP), the prostacyclins and nitric oxide (NO), among others.

Cocoa is a food rich in flavonoids, which stimulate the enzyme activity of endothelial nitric oxide synthase (e-NOS), responsible of the production of NO in vascular smooth muscle. The flavonoids modulate the synthesis of inflammatory substances that are derived from endothelial cells and the immune system.

In a recent study found that with a few grams of cocoa achieves a significant reduction in blood pressure, so the investigators propose a controlled clinical trial to assess the effect of different doses of cocoa on blood pressure and endothelial inflammation in men with essential hypertension, stage I-II without target organ damage, in addition to pharmacologic monotherapy defined for the management of their disease. The investigators hope to determine an optimal dose of cocoa, with long-term effects, by their high content of flavonoids, improves cardiovascular and endothelial parameters with the advantage that it is an economical and easy introduction into the patient's habits.


Condition Intervention
Hypertension
Dietary Supplement: Delivery and return of chocolate
Procedure: Determination of blood pressure
Procedure: Anthropometric Measurements
Procedure: Food Anamnesis
Procedure: Samples: serological tests and culture of mononuclear cells
Procedure: Analysis of cytokine production

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Controlled Clinical Trial of the Effect of Cocoa Consumption in Lowering Blood Pressure and in the Modulation of Endothelial Inflammation in Hypertensive Patients Assigned to an Entity Health Promoting.

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the oxidation of low density lipoproteins after cocoa consumption, in patients with stage I-II hypertension. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Change in the production of inflammatory molecules derived from peripheral blood mononuclear cells of patients with arterial hypertension stage I-II, after cocoa consumption. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Change in platelet aggregation after cocoa consumption, in patients with essential arterial hypertension stage I-II. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: December 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Delivery and return of chocolate
At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
Procedure: Determination of blood pressure
Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.
Procedure: Anthropometric Measurements
The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).
Procedure: Food Anamnesis
With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.
Procedure: Samples: serological tests and culture of mononuclear cells
At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.
Procedure: Analysis of cytokine production
We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.
Active Comparator: 6,5g Dose Group Dietary Supplement: Delivery and return of chocolate
At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
Procedure: Determination of blood pressure
Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.
Procedure: Anthropometric Measurements
The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).
Procedure: Food Anamnesis
With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.
Procedure: Samples: serological tests and culture of mononuclear cells
At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.
Procedure: Analysis of cytokine production
We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.
Active Comparator: 12g Dose Group Dietary Supplement: Delivery and return of chocolate
At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
Procedure: Determination of blood pressure
Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.
Procedure: Anthropometric Measurements
The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).
Procedure: Food Anamnesis
With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.
Procedure: Samples: serological tests and culture of mononuclear cells
At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.
Procedure: Analysis of cytokine production
We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.
Active Comparator: 25g Dose Group Dietary Supplement: Delivery and return of chocolate
At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
Procedure: Determination of blood pressure
Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.
Procedure: Anthropometric Measurements
The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).
Procedure: Food Anamnesis
With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.
Procedure: Samples: serological tests and culture of mononuclear cells
At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.
Procedure: Analysis of cytokine production
We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.
Active Comparator: 50g Dose Group Dietary Supplement: Delivery and return of chocolate
At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
Procedure: Determination of blood pressure
Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.
Procedure: Anthropometric Measurements
The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).
Procedure: Food Anamnesis
With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.
Procedure: Samples: serological tests and culture of mononuclear cells
At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.
Procedure: Analysis of cytokine production
We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Age: 18 - 65 years old
  • Resides in Medellín City
  • Attached from the contributive regimen of Colombian Health System
  • Essential Arterial Hypertension, stage I or II.
  • Be receiving pharmacologic therapy (maximum 2 medications), whose dose has been stable for eight weeks prior to study entry.
  • Voluntary desire to consume 6,5; 12; 25 or 50 grams of chocolate per day for 18 weeks.
  • Voluntary desire to participate in the trial and sign informed consent.

Exclusion Criteria:

  • Secondary hypertension
  • Injury in target organ: heart, kidney, brain and retina
  • 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 and multivitamins
  • During the study excluded any participant to present a sudden increase in blood pressure: SBP greater than or equal to 180 mmHg and/or DBP greater or equal to 110 mm Hg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276951

Contacts
Contact: Mónica L. Giraldo Restrepo, Nurse. PhD (574) 2106474 mlgiraldo@une.net.co

Locations
Colombia
Sede Investigaciones Universitarias, Universidad de Antioquia Recruiting
Medellín, Antioquia, Colombia, 05001000
Contact: Mónica Lucía Giraldo Restrepo, Nurse. PhD Inmunology    (574) 2106474    mlgiraldo@une.net.co   
Principal Investigator: Mónica Lucía Giraldo Restrepo, Nurse. PhD Inmunology         
Sub-Investigator: Héctor Iván García García, MD. Epidemiologist         
Sub-Investigator: Gloria Margarita Alcaraz López, Nutritionist         
Sub-Investigator: Juan Manuel Toro Escobar, Internal Medicine         
Sub-Investigator: José Robinson Ramírez Pineda, Geneticist         
Sub-Investigator: Pablo Javier Grajales, MD.PhD Inmunology         
Sub-Investigator: Carlos J. Jaramillo Gómez, Cardiologist         
Sub-Investigator: Gabriel Bedoya Berrío         
Sponsors and Collaborators
Universidad de Antioquia
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
Principal Investigator: Mónica L. Giraldo Restrepo, Nurse. PhD Universidad de Antioquia
  More Information

Publications:
Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. No abstract available. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

Responsible Party: Mónica Lucía Giraldo Restrepo, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01276951     History of Changes
Other Study ID Numbers: Cacao III
Study First Received: May 24, 2010
Last Updated: January 13, 2011
Health Authority: National Institutes of Health: Colombia

Keywords provided by Universidad de Antioquia:
Cocoa
Chocolate
Endothelial disfunction
Cardiovascular disease
Blood Pressure
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014