Effect of Cocoa Consumption in Cardiovascular and Immune Parameters - Full Text View

Purpose

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.

Condition	Intervention
Arterial Hypertension	Dietary Supplement: Dark chocolate Dietary Supplement: White chocolate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:

Change in diastolic blood pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring

Secondary Outcome Measures:

Change in systolic blood pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
Change in total cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in low density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in high density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in triglycerides levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in hs-CRP [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in IL-1 beta levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in IL-2 levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in tumor necrosis factor alpha levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in flow mediated dilatation of the brachial artery [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	69
Study Start Date:	July 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Dark chocolate Presence of 70% cocoa solids	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

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496235

Locations

Colombia
Sede Investigaciones Universitarias, Universidad de Antioquia
Medellín, Antioquia, Colombia

Sponsors and Collaborators

Universidad de Antioquia

Investigators

Principal Investigator:

Monica L Giraldo, PhD

Universidad de Antioquia

More Information

Publications:

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. Epub 2003 Dec 1.

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; ESH-ESC Task Force on the Management of Arterial Hypertension. 2007 ESH-ESC Practice Guidelines for the Management of Arterial Hypertension: ESH-ESC Task Force on the Management of Arterial Hypertension. J Hypertens. 2007 Sep;25(9):1751-62. No abstract available. Erratum in: J Hypertens. 2007 Oct;25(10):2184.

K Hollenberg N. Vascular action of cocoa flavanols in humans: the roots of the story. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S99-102; discussion S119-21.

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.

Keen CL, Holt RR, Oteiza PI, Fraga CG, Schmitz HH. Cocoa antioxidants and cardiovascular health. Am J Clin Nutr. 2005 Jan;81(1 Suppl):298S-303S. Review.

Selmi C, Mao TK, Keen CL, Schmitz HH, Eric Gershwin M. The anti-inflammatory properties of cocoa flavanols. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S163-71; discussion S172-6. Review.

Desch S, Schmidt J, Kobler D, Sonnabend M, Eitel I, Sareban M, Rahimi K, Schuler G, Thiele H. Effect of cocoa products on blood pressure: systematic review and meta-analysis. Am J Hypertens. 2010 Jan;23(1):97-103. Epub 2009 Nov 12. Review.

Taubert D, Roesen R, Schömig E. Effect of cocoa and tea intake on blood pressure: a meta-analysis. Arch Intern Med. 2007 Apr 9;167(7):626-34.

Grassi D, Necozione S, Lippi C, Croce G, Valeri L, Pasqualetti P, Desideri G, Blumberg JB, Ferri C. Cocoa reduces blood pressure and insulin resistance and improves endothelium-dependent vasodilation in hypertensives. Hypertension. 2005 Aug;46(2):398-405. Epub 2005 Jul 18.

Haukoos JS, Newgard CD. Advanced statistics: missing data in clinical research--part 1: an introduction and conceptual framework. Acad Emerg Med. 2007 Jul;14(7):662-8. Epub 2007 May 30.

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.

Crews WD Jr, Harrison DW, Wright JW. A double-blind, placebo-controlled, randomized trial of the effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health: clinical findings from a sample of healthy, cognitively intact older adults. Am J Clin Nutr. 2008 Apr;87(4):872-80.

Monagas M, Khan N, Andres-Lacueva C, Casas R, Urpí-Sardà M, Llorach R, Lamuela-Raventós RM, Estruch R. Effect of cocoa powder on the modulation of inflammatory biomarkers in patients at high risk of cardiovascular disease. Am J Clin Nutr. 2009 Nov;90(5):1144-50. Epub 2009 Sep 23.

Engler MB, Engler MM, Chen CY, Malloy MJ, Browne A, Chiu EY, Kwak HK, Milbury P, Paul SM, Blumberg J, Mietus-Snyder ML. Flavonoid-rich dark chocolate improves endothelial function and increases plasma epicatechin concentrations in healthy adults. J Am Coll Nutr. 2004 Jun;23(3):197-204.

Muniyappa R, Hall G, Kolodziej TL, Karne RJ, Crandon SK, Quon MJ. Cocoa consumption for 2 wk enhances insulin-mediated vasodilatation without improving blood pressure or insulin resistance in essential hypertension. Am J Clin Nutr. 2008 Dec;88(6):1685-96.

Taubert D, Roesen R, Lehmann C, Jung N, Schomig 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.

Grassi D, Desideri G, Necozione S, Lippi C, Casale R, Properzi G, Blumberg JB, Ferri C. Blood pressure is reduced and insulin sensitivity increased in glucose-intolerant, hypertensive subjects after 15 days of consuming high-polyphenol dark chocolate. J Nutr. 2008 Sep;138(9):1671-6.

Fraga CG, Actis-Goretta L, Ottaviani JI, Carrasquedo F, Lotito SB, Lazarus S, Schmitz HH, Keen CL. Regular consumption of a flavanol-rich chocolate can improve oxidant stress in young soccer players. Clin Dev Immunol. 2005 Mar;12(1):11-7.

Wang-Polagruto JF, Villablanca AC, Polagruto JA, Lee L, Holt RR, Schrader HR, Ensunsa JL, Steinberg FM, Schmitz HH, Keen CL. Chronic consumption of flavanol-rich cocoa improves endothelial function and decreases vascular cell adhesion molecule in hypercholesterolemic postmenopausal women. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S177-86; discussion S206-9.

Holt RR, Actis-Goretta L, Momma TY, Keen CL. Dietary flavanols and platelet reactivity. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S187-96; discussion S206-9. Review.

Murphy KJ, Chronopoulos AK, Singh I, Francis MA, Moriarty H, Pike MJ, Turner AH, Mann NJ, Sinclair AJ. Dietary flavanols and procyanidin oligomers from cocoa (Theobroma cacao) inhibit platelet function. Am J Clin Nutr. 2003 Jun;77(6):1466-73.

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.

Hermann F, Spieker LE, Ruschitzka F, Sudano I, Hermann M, Binggeli C, Lüscher TF, Riesen W, Noll G, Corti R. Dark chocolate improves endothelial and platelet function. Heart. 2006 Jan;92(1):119-20. No abstract available.

Responsible Party:	Monica Lucia Giraldo, Principal Investigator, Universidad de Antioquia
ClinicalTrials.gov Identifier:	NCT01496235 History of Changes
Other Study ID Numbers:	Cacao I
Study First Received:	November 24, 2011
Last Updated:	December 16, 2011
Health Authority:	Colombia: National Institutes of Health

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013