Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587883
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Cocoa flavanols I Other: Control I Other: Cocoa flavanols II Other: Control II Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, double-masked and cross-over dietary intervention study in healthy adults.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : September 5, 2026
Estimated Study Completion Date : September 5, 2026

Arm Intervention/treatment
Experimental: Cocoa Flavanol intervention
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 300 mg of cocoa flavanols per capsule: 900 mg of cocoa flavanols consumed daily for 2 weeks; 2 intervention periods: Cocoa flavanols I and cocoa flavanols II.
Other: Cocoa flavanols I
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.

Other: Cocoa flavanols II
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.

Placebo Comparator: Control intervention
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks; 2 intervention periods: control I and control II.
Other: Control I
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.

Other: Control II
Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.




Primary Outcome Measures :
  1. Individual changes in systolic blood pressure (in office) [ Time Frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention ]
    assessed as systolic blood pressure

  2. Individual changes in diastolic blood pressure (in office) [ Time Frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention ]
    assessed as diastolic blood pressure

  3. Individual changes in augmentation index (in office) [ Time Frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention ]
    assessed as augmentation index

  4. Individual changes in central blood pressure (in office) [ Time Frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention ]
    assessed as central blood pressure

  5. Individual changes in blood pressure (at home) [ Time Frame: Daily for 2 weeks between 0, 2, 4, 6, 8 and 10 weeks of intervention ]
    self monitoring blood pressure

  6. Individual changes in pulse wave velocity (in office) [ Time Frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention ]
    assessed as pulse wave velocity

  7. Individual changes in lipid profile [ Time Frame: Baseline and 2, 4, 6, 8 and 10 weeks following intervention ]
    Total cholesterol, LDL, HDL and Triglycerides


Secondary Outcome Measures :
  1. Individual changes in flavanol metabolites in plasma and urine [ Time Frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention ]
    flavanol/methylxanthine metabolites in plasma and urine

  2. Individual changes in 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

  3. Individual changes in CMP [ Time Frame: Baseline and 2, 4, 6, 8, 10 weeks following intervention ]
    comprehensive metabolic panel

  4. Individual changes in Step test performance [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT03587883


Contacts
Layout table for location contacts
Contact: Jodi L Ensunsa, MS 530-752-0502 jlensunsa@ucdavis.edu
Contact: Jennifer Kimball, MFA 5307548360 jkimball@ucdavis.edu

Locations
Layout table for location information
United States, California
Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis Recruiting
Davis, California, United States, 95616
Contact: Jennifer Kimball, MFA    530-754-8360    jkimball@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Mars, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Carl L Keen, PhD UC Davis
Study Director: Javier I Ottaviani, PhD Mars, Inc.

Publications:
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03587883    
Other Study ID Numbers: 547762
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
flavanol
cocoa flavanols
arterial stiffness
blood pressure
step test