Clinical trial NCT03587883: Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans
Official title: Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: flavanol
cocoa flavanols
arterial stiffness
blood pressure
step test
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Mars, Inc.
First posted: 2018-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-masked and cross-over dietary intervention study in healthy adults.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 25-65 years old
* BMI 18.5 - 34.9 kg/m2
* Weight ≥ 110 pounds
* Previously consumed cocoa and peanut products, with no adverse reactions
* Having completed physical exercise similar to 5 MET within the last 2 months without having any physical limitations \[e.g. i) Brisk walking (at 4 mph); ii) Mowing lawn; iii) Bicycling-light effort (10 mph) and iv) Playing tennis-doubles.\]

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Non-English speaking\*
* BMI ≥ 35 kg/m2
* More than 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous-intensity aerobic activity weekly and more than two days a week of muscle strengthening activities that work all major muscle groups (CDC recommended physical activity guidelines for adults)
* Allergies to nuts, cocoa and chocolate products
* Active avoidance of coffee and caffeinated soft drinks
* A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
* History of clinically significant depression, anxiety or other psychiatric condition
* History of difficult blood draws
* History of Raynaud's disease
* Indications of substance or alcohol abuse within the last 3 years
* Current use of herbal, plant or botanical supplements (multi-vitamin/mineral supplements are allowed)
* Blood Pressure \>140/90 mm Hg
* Blood Pressure \< 100/60 mm Hg, or heart rate \< 50 bpm (due to limitations in the assessment of arterial stiffness
* GI tract disorders, previous GI surgery (except appendectomy)
* Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
* Diarrhea within the last month, or antibiotic intake within the last month
* Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individuals following diets with significant deviations from the average diet
* Metabolic panel results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician
* Cold, flu, or upper respiratory condition at screening
* Currently participating in a clinical or dietary intervention study
* \*Non-English speaking volunteers will be excluded for safety reasons, as we do not have staff that can adequately provide interpretation services that can explain and answer questions with regard to study procedures.

Primary outcomes:
measure: Individual changes in systolic blood pressure (in office)
timeFrame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
measure: Individual changes in diastolic blood pressure (in office)
timeFrame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
measure: Individual changes in augmentation index (in office)
timeFrame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
measure: Individual changes in central blood pressure (in office)
timeFrame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
measure: Individual changes in blood pressure (at home)
timeFrame: Daily for 2 weeks between 0, 2, 4, 6, 8 and 10 weeks of intervention
measure: Individual changes in pulse wave velocity (in office)
timeFrame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
measure: Individual changes in lipid profile
timeFrame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention
Secondary outcomes:
measure: Individual changes in flavanol metabolites in plasma and urine
timeFrame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
measure: Individual changes in methylxanthine metabolites in plasma and urine
timeFrame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
measure: Individual changes in CMP
timeFrame: Baseline and 2, 4, 6, 8, 10 weeks following intervention
measure: Individual changes in Step test performance
timeFrame: Baseline and 2, 4, 6, 8, 10 weeks following 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
affiliation: Mars, Inc.
name: Javier I Ottaviani, PhD
role: STUDY_DIRECTOR
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.