Arterial HypertensionNCT01496235

Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

A study testing Dark chocolate and White chocolate in people with Arterial Hypertension, run by Universidad de Antioquia at 1 site in Colombia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Arterial Hypertension
What is being tested?: Dark chocolate and White chocolate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 1 siteColombia
Study dates: Jul 2009to Jul 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

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Sede Investigaciones Universitarias, Universidad de Antioquia
Medellín, Antioquia

Other trials in Colombia

About this study

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

Conditions: Arterial Hypertension
Being tested: Dark chocolate, White chocolate
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dark chocolateDietary supplement
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
White chocolateDietary supplement
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

Study groups in NCT01496235
Study group	Role	What they receive
Dark chocolate	Active comparator	Presence of 70% cocoa solids Receives: Dietary Supplement: Dark chocolate
White chocolate	Placebo comparator	Not described Receives: Dietary Supplement: White chocolate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in diastolic blood pressure
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
Measured: Baseline and 12 weeks

Secondary outcomes (10)

Change in systolic blood pressure
Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
Measured: Baseline and 12 weeks
Change in total cholesterol
Measured: Baseline and 12 weeks
Change in low density lipoprotein cholesterol
Measured: Baseline and 12 weeks
Change in high density lipoprotein cholesterol
Measured: Baseline and 12 weeks
Change in triglycerides levels
Measured: Baseline and 12 weeks
Change in hs-CRP
Measured: Baseline and 12 weeks
Change in IL-1 beta levels
Measured: Baseline and 12 weeks
Change in IL-2 levels
Measured: Baseline and 12 weeks
Change in tumor necrosis factor alpha levels
Measured: Baseline and 12 weeks
Change in flow mediated dilatation of the brachial artery
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jul 2011

First posted21 Dec 2011 (estimated)
Study startJul 2009
Primary completionJul 2011
Study completionJul 2011

Why it stopped: Difficulties with the patient recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Arterial 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, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01496235
Sponsor's protocol ID: Cacao I
Status last verified: Dec 2011
First submitted: 24 Nov 2011
Last updated: 21 Dec 2011
Results posted: No
Data monitoring committee: Yes

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. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.
PubMed 14656957
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. doi: 10.1097/HJH.0b013e3282f0580f. No abstract available.
PubMed 17762635
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. doi: 10.1097/00005344-200606001-00002.
PubMed 16794463
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. doi: 10.1097/00005344-200606001-00003.
PubMed 16794446
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. doi: 10.1093/ajcn/81.1.298S.
PubMed 15640494
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. doi: 10.1097/00005344-200606001-00010.
PubMed 16794453
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. doi: 10.1038/ajh.2009.213. Epub 2009 Nov 12.
PubMed 19910929
Ried K, Sullivan T, Fakler P, Frank OR, Stocks NP. Does chocolate reduce blood pressure? A meta-analysis. BMC Med. 2010 Jun 28;8:39. doi: 10.1186/1741-7015-8-39.
PubMed 20584271
Taubert 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 17420419
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 16027246
Sabater-Hernandez D, Fikri-Benbrahim O, Faus MJ. [Usefulness of ambulatory blood pressure monitoring for clinical decisions making]. Med Clin (Barc). 2010 Jun 5;135(1):23-9. doi: 10.1016/j.medcli.2009.07.019. Epub 2009 Oct 12. Spanish.
PubMed 19819484
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. doi: 10.1197/j.aem.2006.11.037. Epub 2007 May 30.
PubMed 17538078
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. doi: 10.1042/CS20060048.
PubMed 16551272
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. doi: 10.1093/ajcn/87.4.872.
PubMed 18400709
Monagas M, Khan N, Andres-Lacueva C, Casas R, Urpi-Sarda M, Llorach R, Lamuela-Raventos 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. doi: 10.3945/ajcn.2009.27716. Epub 2009 Sep 23.
PubMed 19776136

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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All Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01496235
Acronym / sponsor ID: Cacao I
Conditions: Arterial Hypertension
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulties with the patient recruitment
Enrolment: 69 participants (actual)
Lead sponsor: Universidad de AntioquiaUniversity, hospital or other
Study start: Jul 2009
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 21 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dark chocolate	Active comparator	Dietary Supplement: Dark chocolatePresence of 70% cocoa solids
White chocolate	Placebo comparator	Dietary Supplement: White chocolate

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (7 listed)

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

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
Dark chocolateEach 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	Dietary supplement	Dark chocolate
White chocolateEach 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	Dietary supplement	White chocolate

Primary outcome

Change in diastolic blood pressure
Time frame: Baseline and 12 weeks
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring

10 secondary outcomes

Change in systolic blood pressure
Time frame: Baseline and 12 weeks
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

Results and safety

The study was stopped early (reason given: Difficulties with the patient recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
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 17762635Mancia 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. doi: 10.1097/HJH.0b013e3282f0580f. No abstract available.
Background: PubMed 16794463K 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. doi: 10.1097/00005344-200606001-00002.
Background: PubMed 16794446McCullough 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.
Background: PubMed 15640494Keen 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. doi: 10.1093/ajcn/81.1.298S.
Background: PubMed 16794453Selmi 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. doi: 10.1097/00005344-200606001-00010.
Background: PubMed 19910929Desch 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. doi: 10.1038/ajh.2009.213. Epub 2009 Nov 12.
Background: PubMed 20584271Ried K, Sullivan T, Fakler P, Frank OR, Stocks NP. Does chocolate reduce blood pressure? A meta-analysis. BMC Med. 2010 Jun 28;8:39. doi: 10.1186/1741-7015-8-39.
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.
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 19819484Sabater-Hernandez D, Fikri-Benbrahim O, Faus MJ. [Usefulness of ambulatory blood pressure monitoring for clinical decisions making]. Med Clin (Barc). 2010 Jun 5;135(1):23-9. doi: 10.1016/j.medcli.2009.07.019. Epub 2009 Oct 12. Spanish.
Background: PubMed 17538078Haukoos 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. doi: 10.1197/j.aem.2006.11.037. Epub 2007 May 30.

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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.

Monica L Giraldo, 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 Dark chocolate and White chocolate in people with Arterial 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Dec 2011. 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 was stopped early (reason given: Difficulties with the patient recruitment). Results are not available in the source record.

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 in diastolic blood pressure (time frame: Baseline and 12 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 NCT01496235, which also lists 26 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 21 Dec 2011.