Clinical trial NCT02447770: Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1
Official title: Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Flavanols
Cocoa flavanols
Blood pressure
Platelet Function
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Flavanols 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. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.


Eligibility criteria: Inclusion Criteria:

* 30-55 years old
* A normal blood chemistry and liver function
* BMI \< 30 kg/m2
* previously consumed cocoa and peanut products, with no adverse reactions

Exclusion Criteria:

* A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
* Allergies to nuts, cocoa and chocolate products
* Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements

Primary outcomes:
measure: Change in blood pressure
timeFrame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
measure: Change in platelet function
timeFrame: Baseline and 14, 28, 42 and 56 days after intervention
measure: Change in metabolic parameters in blood
timeFrame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Secondary outcomes:
measure: Change in plasma concentration of cocoa flavanol metabolites
timeFrame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
measure: Change in plasma concentration of methylxanthines
timeFrame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis
state: California
Study officials:
affiliation: UC Davis
name: Carl L Keen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroeter H, Heiss C, Spencer JP, Keen CL, Lupton JR, Schmitz HH. Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs. Mol Aspects Med. 2010 Dec;31(6):546-57. doi: 10.1016/j.mam.2010.09.008. Epub 2010 Sep 18.
citation: Ottaviani JI, Balz M, Kimball J, Ensunsa JL, Fong R, Momma TY, Kwik-Uribe C, Schroeter H, Keen CL. Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial. Am J Clin Nutr. 2015 Dec;102(6):1425-35. doi: 10.3945/ajcn.115.116178. Epub 2015 Nov 4.