Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans

NCT03587883 | Completed

• 1 other identifier: 547762
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

flavanol; cocoa flavanols; arterial stiffness; blood pressure; step test

Outcome Measures

Primary Outcomes (7)

• Individual changes in systolic blood pressure (in office)

  assessed as systolic blood pressure

  Baseline and 2, 4, 6, 8 and 10 weeks following intervention

• Individual changes in diastolic blood pressure (in office)

  assessed as diastolic blood pressure

  Baseline and 2, 4, 6, 8 and 10 weeks following intervention

• Individual changes in augmentation index (in office)

  assessed as augmentation index

  Baseline and 2, 4, 6, 8 and 10 weeks following intervention

• Individual changes in central blood pressure (in office)

  assessed as central blood pressure

  Baseline and 2, 4, 6, 8 and 10 weeks following intervention

• Individual changes in blood pressure (at home)

  self monitoring blood pressure

  Daily for 2 weeks between 0, 2, 4, 6, 8 and 10 weeks of intervention

• Individual changes in pulse wave velocity (in office)

  assessed as pulse wave velocity

  Baseline and 2, 4, 6, 8 and 10 weeks following intervention

• Individual changes in lipid profile

  Total cholesterol, LDL, HDL and Triglycerides

  Baseline and 2, 4, 6, 8 and 10 weeks following intervention

Secondary Outcomes (4)

• Individual changes in flavanol metabolites in plasma and urine

  Baseline and 2, 4, 6, 8, 10 weeks following intervention

• Individual changes in methylxanthine metabolites in plasma and urine

  Baseline and 2, 4, 6, 8, 10 weeks following intervention

• Individual changes in CMP

  Baseline and 2, 4, 6, 8, 10 weeks following intervention

• Individual changes in Step test performance

  Baseline and 2, 4, 6, 8, 10 weeks following intervention

Study Arms (2)

Cocoa Flavanol intervention

EXPERIMENTAL

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; Other: Cocoa flavanols II

Control intervention

PLACEBO COMPARATOR

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

Other: Control I; Other: Control II

Interventions

Cocoa flavanols I OTHER

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

Cocoa Flavanol intervention

Control I OTHER

Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.

Control intervention

Cocoa flavanols II OTHER

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

Cocoa Flavanol intervention

Control II OTHER

Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.

Control intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[e.g. i) Brisk walking (at 4 mph); ii) Mowing lawn; iii) Bicycling-light effort (10 mph) and iv) Playing tennis-doubles.\]

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• Mars, Inc.: collaborator

Study Sites (1)

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis

Davis, California, 95616, United States

Location

Related Publications (1)

• 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.

  PMID: 20854838 BACKGROUND

Study Officials

• Carl L Keen, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

• Javier I Ottaviani, PhD

  Mars, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-masked and cross-over dietary intervention study in healthy adults.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 16, 2018
• Study Start: March 23, 2018
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)