Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood Pressure
Information source: Universidad de Antioquia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Delivery and return of chocolate (Dietary Supplement); Determination of blood pressure (Procedure); Anthropometric Measurements (Procedure); Food Anamnesis (Procedure); Samples: serological tests and culture of mononuclear cells (Procedure); Analysis of cytokine production (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Universidad de Antioquia Official(s) and/or principal investigator(s): Mónica L. Giraldo Restrepo, Nurse. PhD, Principal Investigator, Affiliation: Universidad de Antioquia
Overall contact: Mónica L. Giraldo Restrepo, Nurse. PhD, Phone: (574) 2106474, Email: mlgiraldo@une.net.co
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.
Secondary outcome: Change in the oxidation of low density lipoproteins after cocoa consumption, in patients with stage I-II hypertension.Change in the production of inflammatory molecules derived from peripheral blood mononuclear cells of patients with arterial hypertension stage I-II, after cocoa consumption. Change in platelet aggregation after cocoa consumption, in patients with essential arterial hypertension stage I-II.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Mónica L. Giraldo Restrepo, Nurse. PhD, Phone: (574) 2106474, Email: mlgiraldo@une.net.co
Sede Investigaciones Universitarias, Universidad de Antioquia, Medellín, Antioquia 05001000, Colombia; Recruiting Mónica Lucía Giraldo Restrepo, Nurse. PhD Inmunology, Phone: (574) 2106474, Email: mlgiraldo@une.net.co Mónica Lucía Giraldo Restrepo, Nurse. PhD Inmunology, Principal 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, Sub-Investigator
Additional Information
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Schroeter H, Heiss C, Balzer J, Kleinbongard P, Keen CL, Hollenberg NK, Sies H, Kwik-Uribe C, Schmitz HH, Kelm M. (-)-Epicatechin mediates beneficial effects of flavanol-rich cocoa on vascular function in humans. Proc Natl Acad Sci U S A. 2006 Jan 24;103(4):1024-9. Epub 2006 Jan 17. McCullough ML, Chevaux K, Jackson L, Preston M, Martinez G, Schmitz HH, Coletti C, Campos H, Hollenberg NK. Hypertension, the Kuna, and the epidemiology of flavanols. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S103-9; discussion 119-21. Fisher ND, Sorond FA, Hollenberg NK. Cocoa flavanols and brain perfusion. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S210-4. Tsuruchi N, Jimi S. [A case of recurrent endometrial cancer successfully treated with oral administration of etoposide]. Gan To Kagaku Ryoho. 1992 Jan;19(1):103-5. Japanese. Farouque HM, Leung M, Hope SA, Baldi M, Schechter C, Cameron JD, Meredith IT. Acute and chronic effects of flavanol-rich cocoa on vascular function in subjects with coronary artery disease: a randomized double-blind placebo-controlled study. Clin Sci (Lond). 2006 Jul;111(1):71-80. Taubert D, Roesen R, Lehmann C, Jung N, Schömig E. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide: a randomized controlled trial. JAMA. 2007 Jul 4;298(1):49-60. Taubert D, Berkels R, Roesen R, Klaus W. Chocolate and blood pressure in elderly individuals with isolated systolic hypertension. JAMA. 2003 Aug 27;290(8):1029-30. Grassi D, Lippi C, Necozione S, Desideri G, Ferri C. Short-term administration of dark chocolate is followed by a significant increase in insulin sensitivity and a decrease in blood pressure in healthy persons. Am J Clin Nutr. 2005 Mar;81(3):611-4. Heiss C, Dejam A, Kleinbongard P, Schewe T, Sies H, Kelm M. Vascular effects of cocoa rich in flavan-3-ols. JAMA. 2003 Aug 27;290(8):1030-1. 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Starting date: December 2008
Last updated: January 13, 2011
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