Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis
Davis, California, 95616, United States
NCT Number: NCT03587883
A randomized, double-masked and cross-over dietary intervention study to investigate the effects of diet supplementation with cocoa flavanols on arterial stiffness in healthy adult human subjects.
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Notify Me25 year–65 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
Cocoa flavanols (CF) are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. Flavanols encompass a group of different compounds, and the final profile of flavanols in foods will depend on multiple factors including plant origin, time of harvesting, storage, food processing, and cooking techniques. The term "cocoa flavanols" (CF) as used here refers to the particular profile of flavanols and procyanidins naturally found in cocoa beans, and CF mainly consist of the monomeric flavanol (-)-epicatechin and its oligomeric derivatives (procyanidins) containing up to 10 monomer subunits.
Accumulating data resulting from dietary intervention studies suggest that the intake of diets rich in flavanols can exert a beneficial cardiovascular health effect in humans. However, most of these investigations have been conducted with patients with diverse health complications (e.g. hypertension, diabetes and coronary heart disease) rather than healthy subjects. Thus, the interpretation of these data in the context of nutrition, primary prevention, and dietary recommendations is limited. In the current study, the investigators propose to investigate the effects of cocoa flavanol intake on arterial stiffness in a healthy population of adults. The investigators submit that this investigation will provide novel insights into the potential health benefits of dietary flavanols and procyanidins in the context of cardiovascular health in humans. The data resulting from this study will be key to the design of larger scale studies in this context, which are needed to comprehensively study the role of dietary flavanols and procyanidins with regard to potential dietary recommendations and public health.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as systolic blood pressure
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as diastolic blood pressure
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as augmentation index
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as central blood pressure
Time frame: Daily for 2 weeks between 0, 2, 4, 6, 8 and 10 weeks of intervention
self monitoring blood pressure
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
assessed as pulse wave velocity
Time frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Total cholesterol, LDL, HDL and Triglycerides
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
flavanol/methylxanthine metabolites in plasma and urine
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
flavanol/methylxanthine metabolites in plasma and urine
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
comprehensive metabolic panel
Time frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
Volunteers will be asked to step up and down on a platform (7 inches high) at a rate of 23 steps per minute for no more than 3 minutes. Blood pressure will be measured before and after the step test.
University of California, Davis
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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