Effects of Cocoa Intake on Blood Pressure in Elderly Individuals With Mild Hypertension
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|ClinicalTrials.gov Identifier: NCT00421499|
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : January 12, 2007
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 or disease||Intervention/treatment||Phase|
|Hypertension||Drug: dark chocolate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2005|
|Study Completion Date :||May 2005|
- changes in systolic and diastolic blood pressure
- plasma levels of bioactive nitric oxide, 8-isoprostane, cocoa polyphenols
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421499
|Department of Pharmacology, University of Cologne|
|Cologne, Germany, 50931|
|Principal Investigator:||Dirk Taubert||Department of Pharmacology, University of Cologne|