Trial record 28 of 215 for:    chocolate

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
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014