Effects of Cocoa Intake on Blood Pressure in Elderly Individuals With Mild Hypertension - Full Text View

Sponsored by:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00421499

Purpose

Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and all-cause mortality in observational studies. Short-term intervention studies indicate that high doses of cocoa improve endothelial function and reduce blood pressure (BP), but the clinical impact of long-term intake of small dietary amounts of cocoa on BP and the underlying BP lowering mechanisms are unclear. We hypothesized that cocoa consumption lowers blood pressure by augmentation of the circulating vasodilative nitric oxide (NO) pool due to the action of the cocoa polyphenols at the vascular endothelium. To test this hypothesis, we will conduct a randomized single-blind, parallel group study in subjects with mild essential hypertension to evaluate the effects of polyphenol-rich dark chocolate versus polyphenol-free white chocolate on blood pressure and plasma levels of cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress. After a 7 day cocoa-free run-in period, 44 subjects will be 1:1 randomized to receive over 18 weeks daily doses of either dark chocolate (6.3 g per day with a total of 30 mg of polyphenols and 30 kcal) or polyphenol free white chocolate (5.6 g per day with 30 kcal, containing similar amounts of macronutrients, electrolytes and vitamins). Subjects will be counseled to maintain an isocaloric diet and to abstain from other cocoa products during the study. Blood pressure and plasma parameters will be assessed in each subject after the run-in period and after 6, 12, and 18 weeks of treatment.

Condition	Intervention	Phase
Hypertension	Drug: dark chocolate	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled, Parallel Group, Single Blinded, Phase 1 Study That Investigates the Effects of Regular Daily Intake of Small Amounts of Dark or White Chocolate on Blood Pressure in Elderly Individuals With Mild Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Diets High Blood Pressure

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

changes in systolic and diastolic blood pressure

Secondary Outcome Measures:

plasma levels of bioactive nitric oxide, 8-isoprostane, cocoa polyphenols

Estimated Enrollment:	44
Study Start Date:	January 2005
Estimated Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects between the ages of 55 - 75 years in good general health with high normal blood pressure (between 130/80 and 140/90 mmHg) or mild hypertension (blood pressure between 140/90 and 160/100 mmHg)on no medication or nutritional supplements
Non-manual workers with a household income > 20,000 €/year
Normal plasma lipids (total plasma cholesterol < 6.18 mmol/L
LDL < 4.11 mmol/L
HDL > 0.9 mmol/L
Triacylglycerols < 1.8 mmol/L) and normal plasma glucose (fasting plasma glucose 4.2-6.4 mmol/L).
If a subject's blood pressure exceeds 170/100 mmHg on a single visit, the subject will be withdrawn from the study and referred to appropriate antihypertensive therapy.

Exclusion Criteria:

Subjects are excluded if they have:

Cardiovascular diseases (other than hypertension)
Diabetes mellitus
Hyper-/dyslipidemia
Gastrointestinal diseases
Hepatic and renal disorders
Pulmonary diseases
Coagulopathy
Cancer
Psychiatric disorders
Alcohol or drug dependence
Seizure disorders
History of organ transplantation
Surgery within the last 12 months
Positive tests for HIV, hepatitis B or C.

Subjects are excluded if they have:

A body-mass index of more than 27.5 or less than 18.5 kg/m2
Actively smoked tobacco within the last five years
Regularly use medications
Used any medication within the last two weeks before entry
Use vitamin, mineral or polyphenol supplements or functional food.

Subjects will be excluded if they are unable to give informed consent for all procedures; or subjects who are not capable or willing to appear for controlling visits.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421499

Locations

Germany
Department of Pharmacology, University of Cologne
Cologne, Germany, 50931

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:

Dirk Taubert

Department of Pharmacology, University of Cologne

More Information

Publications:

Taubert D, Berkels R, Roesen R, Klaus W. Chocolate and blood pressure in elderly individuals with isolated systolic hypertension. JAMA. 2003 Aug 27;290(8):1029-30. No abstract available.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	ECA-02-005
Study First Received:	January 11, 2007
Last Updated:	January 11, 2007
ClinicalTrials.gov Identifier:	NCT00421499 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 09, 2009