NCT02447783

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 long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study is a continuation of a previous study investigating the consumptions of increasing amounts 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
75

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.5 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

6 months

First QC Date

May 15, 2015

Last Update Submit

May 24, 2017

Conditions

Healthy

Keywords

FlavanolsCocoa flavanolsBlood pressurePlatelet Function

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    Blood pressure will be measured using standard techniques.

    Baseline (day 0) and 6,12 and 14 weeks after intervention

Secondary Outcomes (3)

  • Change in platelet function

    Baseline and 6, 12 and 14 weeks after intervention

  • Change in 24 h ambulatory blood pressure

    Baseline (day 0) and 12 weeks after intervention

  • Change in metabolic parameters in blood

    Baseline (day 0) and 6, 12 and 14 weeks after intervention

Other Outcomes (2)

  • Change in plasma concentration of cocoa flavanol metabolites

    Baseline (day 0) and 6, 12 and 14 weeks after intervention

  • Change in plasma concentration of methylxanthines

    Baseline (day 0) and 6, 12, and 14 weeks after intervention

Study Arms (2)

Control, Flavanol-free intervention

PLACEBO COMPARATOR

Intake of flavanol-free, macro- and micro-nutrient matched control capsules

Dietary Supplement: Control Capsules

CF intervention

ACTIVE COMPARATOR

Intake of capsules containing Mars Cocoa Extract Capsules manufactured by the Cocoapro® process and providing 500 mg of cocoa flavanols per capsule

Dietary Supplement: Mars Cocoa Extract Capsules

Interventions

Control CapsulesDIETARY_SUPPLEMENT

Cocoa-based, flavanol-free, control-matched capsules consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).

Control, Flavanol-free intervention
Mars Cocoa Extract CapsulesDIETARY_SUPPLEMENT

Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 500 mg of cocoa flavanols per capsule consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).

CF intervention

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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)