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Trial record 7 of 20 for:    theobromine

Food Matrix Effect on Flavanol Absorption, Metabolism and Excretion: Methylxanthines

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526107
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Healthy Other: CF Control Other: CF-Theobromine Other: CF-Caffeine Not Applicable

Detailed Description:
Flavonoids, including the sub groups of Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods and beverages has been associated with improvements in cardiovascular health. In this context, there exists a great interest in describing the absorption, metabolism and excretion of F in humans, as it is thought that F-derived metabolites present in circulation are the mediators of F-beneficial effects in humans. Recently, the investigators described a series of F-derived metabolites in circulation that are present after the consumption of a single acute intake amount of F in humans as well as F-metabolites derived from the metabolic activity of the gut microbiome. A key question, however, is if the metabolites the investigators observed after a single acute feeding are the same as those that occur in individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism of numerous other xenobiotics have shown that the profile of metabolites can greatly vary over time, as well as with the amount of the xenobiotic ingested. In this context, the investigators submit it is important to assess whether or not there are food matrix-dependent effects on the levels and profile of F-derived metabolites in humans. The investigators suggest the information that will be obtained from the outlined work will be particularly timely given ongoing discussion concerning the possible generation of dietary recommendations for F-rich foods and increasing interest in the putative health effects of F intake in humans.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Dietary intervention study in healthy young adult males
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Food Matrix Effect on Flavanol Absorption, Metabolism and Excretion: Methylxanthines
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Theobromine

Arm Intervention/treatment
Active Comparator: CF Control
CF Control: 583 mg of cocoa flavanols, <1 mg caffeine and <1 mg theobromine
Other: CF Control
CF Control: 583 mg of cocoa flavanols, <1 mg caffeine and <1 mg theobromine

Experimental: CF-Theobromine
CF-Theobromine: 566 mg of cocoa flavanols, 11 mg caffeine and 93 mg theobromine
Other: CF-Theobromine
CF-Theobromine: 566 mg of cocoa flavanols, 11 mg caffeine and 93 mg theobromine

Experimental: CF-Caffeine
CF-Caffeine: 583 mg of cocoa flavanols, 112 mg caffeine and <1 mg theobromine(Experimental)
Other: CF-Caffeine
CF-Caffeine: 583 mg of cocoa flavanols, 112 mg caffeine and <1 mg theobromine




Primary Outcome Measures :
  1. Flavanol metabolites in plasma [ Time Frame: Before to 6 h post test material intake ]
    Plasma concentration of flavanol metabolites

  2. Flavanol metabolites in urine [ Time Frame: 12 h before to 24 h post test material intake ]
    Amount of flavanols metabolites excreted in urine


Secondary Outcome Measures :
  1. Methylxanthines in plasma [ Time Frame: Before to 6 h post test material intake ]
    Plasma concentration of methylxanthines and methylxanthine metabolites

  2. Methylxanthines in urine [ Time Frame: 12 h before to 24 h post test material intake ]
    Amount of methylxanthines and methylxanthine metabolites excreted in urine



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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 3 months, or antibiotic intake within the last 3 months
  • 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 and cholesterol 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

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): NCT03526107


Locations
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United States, California
Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis
Davis, California, United States, 95616
UC Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Mars, Inc.
Investigators
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Principal Investigator: Carl L Keen, PhD Mars, Inc.
Study Director: Javier I Ottaviani, PhD Mars, Inc.

Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03526107     History of Changes
Other Study ID Numbers: 429275-T
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only researchers listed in the protocol and approved by the IRB will have access to IPD.

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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
ADME
polyphenols
cocoa
epicatechin
methylxanthine
caffeine
Additional relevant MeSH terms:
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Theobromine
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents