NCT02447770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 15, 2015

Last Update Submit

May 26, 2017

Conditions

Healthy

Keywords

FlavanolsCocoa flavanolsBlood pressurePlatelet Function

Outcome Measures

Primary Outcomes (3)

  • Change in blood pressure

    Blood pressure will be measured using standard techniques.

    Baseline (day 0) and 14, 28, 42 and 56 days after intervention

  • Change in platelet function

    Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation.

    Baseline and 14, 28, 42 and 56 days after intervention

  • Change in metabolic parameters in blood

    Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting.

    Baseline (day 0) and 14, 28, 42 and 56 days after intervention

Secondary Outcomes (2)

  • Change in plasma concentration of cocoa flavanol metabolites

    Baseline (day 0) and 14, 28, 42 and 56 days after intervention

  • Change in plasma concentration of methylxanthines

    Baseline (day 0) and 14, 28, 42 and 56 days after intervention

Study Arms (1)

Cocoa Flavanol intake escalation

EXPERIMENTAL

Ingestion of increasing number of capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process (500 mg of cocoa flavanols/capsule) during 6 weeks followed by a 2 week of washout (no capsule intake)

Dietary Supplement: Mars Cocoa Extract Capsules

Interventions

Mars Cocoa Extract CapsulesDIETARY_SUPPLEMENT

Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 500 mg of cocoa flavanols per capsule: 1000 mg of cocoa flavanols consumed daily during week 1 and 2, 1500 mg of cocoa flavanols consumed daily during week 3 and 4, and 2000 mg of cocoa flavanols consumed daily during week 5 and 6, and no capsule consumed (washout) during week 7 and 8.

Cocoa Flavanol intake escalation

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Davis, California, 95616, United States

Location

Related Publications (2)

  • 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: 20854838BACKGROUND

  • 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.

    PMID: 26537937DERIVED

Study Officials

  • Carl L Keen, PhD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

May 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)