NCT03526107

Brief Summary

Dietary intervention study in healthy young adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of methylxanthines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

February 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

May 3, 2018

Last Update Submit

October 6, 2022

Conditions

Healthy

Keywords

flavanolADMEpolyphenolscocoaepicatechinmethylxanthinecaffeine

Outcome Measures

Primary Outcomes (2)

  • Flavanol metabolites in plasma

    Plasma concentration of flavanol metabolites

    Before to 6 h post test material intake

  • Flavanol metabolites in urine

    Amount of flavanols metabolites excreted in urine

    12 h before to 24 h post test material intake

Secondary Outcomes (2)

  • Methylxanthines in plasma

    Before to 6 h post test material intake

  • Methylxanthines in urine

    12 h before to 24 h post test material intake

Study Arms (3)

CF Control

ACTIVE COMPARATOR

CF Control: 587 mg of cocoa flavanols (101 mg epicatechin), \<1 mg caffeine and \<1 mg theobromine

Other: CF Control

CF-Theobromine

EXPERIMENTAL

CF-Theobromine: 575 mg of cocoa flavanols (102 mg epicatechin), 11 mg caffeine and 93 mg theobromine

Other: CF-Theobromine

CF-Caffeine

EXPERIMENTAL

CF-Caffeine: 587 mg of cocoa flavanols (101 mg epicatechin), 112 mg caffeine and \<1 mg theobromine(Experimental)

Other: CF-Caffeine

Interventions

CF ControlOTHER

CF Control: 587 mg of cocoa flavanols, \<1 mg caffeine and \<1 mg theobromine

CF Control
CF-TheobromineOTHER

CF-Theobromine: 575 mg of cocoa flavanols, 11 mg caffeine and 93 mg theobromine

CF-Theobromine
CF-CaffeineOTHER

CF-Caffeine: 587 mg of cocoa flavanols, 112 mg caffeine and \<1 mg theobromine

CF-Caffeine

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No prescription medications
  • BMI 18.5 - 29.9 kg/m2
  • Weight ≥ 110 pounds
  • previously consumed cocoa, peanut, parsley, celery and chamomile products with no adverse reactions

You may not qualify if:

  • Adults unable to consent
  • Prisoners
  • Non-English speaking\*
  • BMI ≥ 30 kg/m2
  • Performing vigorous physical activity (i.e. more than 6 MET; metabolic equivalence of task as defined by CDC and ACSM guidelines (http://www.cdc.gov/physicalactivity/everyone/glossary/index.html#vig-intensity; and http://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA\_Intensity\_table\_2\_1.pdf ) for more than 3 days a week.
  • Dietary allergies including those to nuts, cocoa and chocolate products, parsley, celery and chamomile.
  • Active avoidance of coffee and caffeinated soft drinks
  • Under current medical supervision
  • A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
  • History of clinically significant depression, anxiety or other psychiatric condition
  • History of Raynaud's disease
  • History of difficult blood draws
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Davis, California, 95616, United States

Location

UC Davis

Davis, California, 95616, United States

Location

Related Publications (6)

  • 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, Momma TY, Kuhnle GK, Keen CL, Schroeter H. Structurally related (-)-epicatechin metabolites in humans: assessment using de novo chemically synthesized authentic standards. Free Radic Biol Med. 2012 Apr 15;52(8):1403-12. doi: 10.1016/j.freeradbiomed.2011.12.010. Epub 2011 Dec 23.

    PMID: 22240152BACKGROUND

  • Koster H, Halsema I, Scholtens E, Knippers M, Mulder GJ. Dose-dependent shifts in the sulfation and glucuronidation of phenolic compounds in the rat in vivo and in isolated hepatocytes. The role of saturation of phenolsulfotransferase. Biochem Pharmacol. 1981 Sep 15;30(18):2569-75. doi: 10.1016/0006-2952(81)90584-0. No abstract available.

    PMID: 6946775BACKGROUND

  • McCullough ML, Chevaux K, Jackson L, Preston M, Martinez G, Schmitz HH, Coletti C, Campos H, Hollenberg NK. Hypertension, the Kuna, and the epidemiology of flavanols. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S103-9; discussion 119-21. doi: 10.1097/00005344-200606001-00003.

    PMID: 16794446BACKGROUND

  • Heiss C, Kleinbongard P, Dejam A, Perre S, Schroeter H, Sies H, Kelm M. Acute consumption of flavanol-rich cocoa and the reversal of endothelial dysfunction in smokers. J Am Coll Cardiol. 2005 Oct 4;46(7):1276-83. doi: 10.1016/j.jacc.2005.06.055.

    PMID: 16198843BACKGROUND

  • Ottaviani JI, Fong RY, Borges G, Kimball J, Ensunsa JL, Medici V, Pourshahidi LK, Kane E, Ward K, Durkan R, Dobani S, Lawther R, O'Connor G, Gill CIR, Schroeter H, Crozier A. Flavan-3-ol-methylxanthine interactions: Modulation of flavan-3-ol bioavailability in volunteers with a functional colon and an ileostomy. Free Radic Biol Med. 2023 Feb 20;196:1-8. doi: 10.1016/j.freeradbiomed.2023.01.003. Epub 2023 Jan 5.

    PMID: 36621554DERIVED

Study Officials

  • Carl L Keen, PhD

    Mars, Inc.

    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
Model Details: Dietary intervention study in healthy young adult males
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

February 16, 2017

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Only researchers listed in the protocol and approved by the IRB will have access to IPD.

Locations

US(2)