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Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

This study has been terminated.
(Difficulties with the patient recruitment)
Sponsor:
Information provided by (Responsible Party):
Monica Lucia Giraldo, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01496235
First received: November 24, 2011
Last updated: December 16, 2011
Last verified: December 2011
  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:


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
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: 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:
Sabater D, Fikri-Benbrahim O, Faus MJ. Utilidad de la monitorización ambulatoria de la presión arterial en la toma de decisiones clínicas . Med Clin (Barc) 2010;135(1):23-9.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014