HypertensionNCT01276951
Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood Pressure
A study testing Delivery and return of chocolate, Determination of blood pressure and Anthropometric Measurements in people with Hypertension, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Delivery and return of chocolate, Determination of blood pressure and Anthropometric Measurements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteColombia
- Study dates
- Dec 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Sede Investigaciones Universitarias, Universidad de Antioquia
Medellín, Antioquia, 05001000
About this study
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.
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.
- Conditions
- Hypertension
- Being tested
- Delivery and return of chocolate, Determination of blood pressure, Anthropometric Measurements, Food Anamnesis, Samples: serological tests and culture of mononuclear cells
- Keywords
- Cocoa, Chocolate, Endothelial disfunction, Cardiovascular disease, Blood Pressure, Hypertension
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery and return of chocolateDietary supplement
At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
Determination of blood pressureProcedure or surgery
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.
Anthropometric MeasurementsProcedure or surgery
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).
Food AnamnesisProcedure or surgery
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.
Samples: serological tests and culture of mononuclear cellsProcedure or surgery
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.
Analysis of cytokine productionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: 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 |
| 6,5g Dose Group | Active comparator | Not described Receives: 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 |
| 12g Dose Group | Active comparator | Not described Receives: 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 |
| 25g Dose Group | Active comparator | Not described Receives: 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 |
| 50g Dose Group | Active comparator | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.
Measured: 18 weeks
Secondary outcomes (3)
Change in the oxidation of low density lipoproteins after cocoa consumption, in patients with stage I-II hypertension.
Measured: 18 weeks
Change in the production of inflammatory molecules derived from peripheral blood mononuclear cells of patients with arterial hypertension stage I-II, after cocoa consumption.
Measured: 18 weeks
Change in platelet aggregation after cocoa consumption, in patients with essential arterial hypertension stage I-II.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startDec 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Sponsor
- Investigators
- Mónica L. Giraldo Restrepo, Nurse. PhD, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276951
- Sponsor's protocol ID
- Cacao III
- Status last verified
- Jan 2017
- First submitted
- 24 May 2010
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1161/01.HYP.0000174990.46027.70. Epub 2005 Jul 18.
PubMed 16027246WHO publishes definitive atlas on global heart disease and stroke epidemic. Indian J Med Sci. 2004 Sep;58(9):405-6. No abstract available.
PubMed 15902773Oparil S, Zaman MA, Calhoun DA. Pathogenesis of hypertension. Ann Intern Med. 2003 Nov 4;139(9):761-76. doi: 10.7326/0003-4819-139-9-200311040-00011. No abstract available.
PubMed 14597461Cifkova R. The burden of hypertension and inadequate control in populations. J Hypertens. 2006 May;24(5):807-9. doi: 10.1097/01.hjh.0000222745.52325.e7. No abstract available.
PubMed 16612237Chobanian 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. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.
PubMed 14656957Kearney PM, Whelton M, Reynolds K, Whelton PK, He J. Worldwide prevalence of hypertension: a systematic review. J Hypertens. 2004 Jan;22(1):11-9. doi: 10.1097/00004872-200401000-00003.
PubMed 15106785Aristizabal D GE, McEwen J, Caulfiel M, Mendez J, Medina E, Zapata N, Correa M. Bases genéticas de la hipertension arterial esencial en Colombia: avances en nueve años de estudio. Revista Colombiana de Cardiología. 12(6), 2006.
Beevers G, Lip GY, O'Brien E. ABC of hypertension: The pathophysiology of hypertension. BMJ. 2001 Apr 14;322(7291):912-6. doi: 10.1136/bmj.322.7291.912. No abstract available.
PubMed 11302910Mancia 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. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available.
PubMed 17563527Steinberg D. Atherogenesis in perspective: hypercholesterolemia and inflammation as partners in crime. Nat Med. 2002 Nov;8(11):1211-7. doi: 10.1038/nm1102-1211. No abstract available.
PubMed 12411947Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199Taubert D, Roesen R, Schomig E. Effect of cocoa and tea intake on blood pressure: a meta-analysis. Arch Intern Med. 2007 Apr 9;167(7):626-34. doi: 10.1001/archinte.167.7.626.
PubMed 17420419Schroeter 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. doi: 10.1073/pnas.0510168103. Epub 2006 Jan 17.
PubMed 16418281McCullough 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. doi: 10.1097/00005344-200606001-00003.
PubMed 16794446Fisher ND, Sorond FA, Hollenberg NK. Cocoa flavanols and brain perfusion. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S210-4. doi: 10.1097/00005344-200606001-00017.
PubMed 16794460
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01276951
- Acronym / sponsor ID
- Cacao III
- Conditions
- Hypertension
- Keywords
- Cocoa, Chocolate, Endothelial disfunction, Cardiovascular disease, Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Dec 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | 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 |
| 6,5g Dose Group | Active comparator | 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 |
| 12g Dose Group | Active comparator | 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 |
| 25g Dose Group | Active comparator | 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 |
| 50g Dose Group | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery and return of chocolateAt baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned. | Dietary supplement | 12g Dose Group, 25g Dose Group, 50g Dose Group, 6,5g Dose Group, Placebo |
| Determination of blood pressureBlood 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 or surgery | 12g Dose Group, 25g Dose Group, 50g Dose Group, 6,5g Dose Group, Placebo |
| Anthropometric MeasurementsThe 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 or surgery | 12g Dose Group, 25g Dose Group, 50g Dose Group, 6,5g Dose Group, Placebo |
| Food AnamnesisWith 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 or surgery | 12g Dose Group, 25g Dose Group, 50g Dose Group, 6,5g Dose Group, Placebo |
| Samples: serological tests and culture of mononuclear cellsAt 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 or surgery | 12g Dose Group, 25g Dose Group, 50g Dose Group, 6,5g Dose Group, Placebo |
| Analysis of cytokine productionWe 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. | Procedure or surgery | 12g Dose Group, 25g Dose Group, 50g Dose Group, 6,5g Dose Group, Placebo |
Primary outcome
Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.
Time frame: 18 weeks
3 secondary outcomes
Change in the oxidation of low density lipoproteins after cocoa consumption, in patients with stage I-II hypertension.
Time frame: 18 weeks
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
Change in platelet aggregation after cocoa consumption, in patients with essential arterial hypertension stage I-II.
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Background: PubMed 16027246Grassi 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. doi: 10.1161/01.HYP.0000174990.46027.70. Epub 2005 Jul 18.
- Background: PubMed 15902773WHO publishes definitive atlas on global heart disease and stroke epidemic. Indian J Med Sci. 2004 Sep;58(9):405-6. No abstract available.
- Background: PubMed 14597461Oparil S, Zaman MA, Calhoun DA. Pathogenesis of hypertension. Ann Intern Med. 2003 Nov 4;139(9):761-76. doi: 10.7326/0003-4819-139-9-200311040-00011. No abstract available.
- Background: PubMed 16612237Cifkova R. The burden of hypertension and inadequate control in populations. J Hypertens. 2006 May;24(5):807-9. doi: 10.1097/01.hjh.0000222745.52325.e7. No abstract available.
- Background: PubMed 14656957Chobanian 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. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.
- Background: PubMed 15106785Kearney PM, Whelton M, Reynolds K, Whelton PK, He J. Worldwide prevalence of hypertension: a systematic review. J Hypertens. 2004 Jan;22(1):11-9. doi: 10.1097/00004872-200401000-00003.
- BackgroundAristizabal D GE, McEwen J, Caulfiel M, Mendez J, Medina E, Zapata N, Correa M. Bases genéticas de la hipertension arterial esencial en Colombia: avances en nueve años de estudio. Revista Colombiana de Cardiología. 12(6), 2006.
- Background: PubMed 11302910Beevers G, Lip GY, O'Brien E. ABC of hypertension: The pathophysiology of hypertension. BMJ. 2001 Apr 14;322(7291):912-6. doi: 10.1136/bmj.322.7291.912. No abstract available.
- Background: PubMed 17563527Mancia 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. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available.
- Background: PubMed 12411947Steinberg D. Atherogenesis in perspective: hypercholesterolemia and inflammation as partners in crime. Nat Med. 2002 Nov;8(11):1211-7. doi: 10.1038/nm1102-1211. No abstract available.
- Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
- Background: PubMed 17420419Taubert D, Roesen R, Schomig E. Effect of cocoa and tea intake on blood pressure: a meta-analysis. Arch Intern Med. 2007 Apr 9;167(7):626-34. doi: 10.1001/archinte.167.7.626.
- Individual participant dataSharing planned: No
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Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mónica L. Giraldo Restrepo, Nurse. PhD principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery and return of chocolate, Determination of blood pressure and Anthropometric Measurements in people with Hypertension, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa. (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01276951, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.