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Trial record 15 of 86 for:    catechin

Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin in Humans

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ClinicalTrials.gov Identifier: NCT01969994
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Collaborators:
Covance
Mars, Inc.
Information provided by (Responsible Party):
The Institutes for Pharmaceutical Discovery, LLC

Brief Summary:
The purpose of this study is to determine the absorption, metabolism and excretion of (-)-epicatechin using the radiolabeled tracer (-)-[2-14C]epicatechin in healthy male volunteers observing a flavanol-/procyanidin-controlled background diet.

Condition or disease Intervention/treatment Phase
ADME Other: Controlled dietary background Other: (−)-[2-14C]epicatechin intake Not Applicable

Detailed Description:
Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds commonly present in the human diet. Accumulating data demonstrate a causal role for dietary flavanols in mediating the cardiovascular benefits associated with the consumption of flavanol-/procyanidin-containing foods. In this context, there exists a great interest in understanding the absorption, distribution, metabolism and excretion (ADME) of flavanols in humans. While significant advances in understanding the ADME of flavanols were made, the data obtained thus far remain fairly preliminary and with significant shortfalls and seeming contradictions. Aimed at addressing the challenges and gaps of previous investigations, this study will investigate the ADME of (-)-epicatechin, one of the most abundant dietary flavanols, following the intake of radiolabeled (−)-[2-14C]epicatechin by healthy humans observing a flavanol-/procyanidin-controlled background diet.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin Following Oral Intake
Study Start Date : December 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

Arm Intervention/treatment
Experimental: Controlled dietary background & (−)-[2-14C]epicatechin intake Other: Controlled dietary background
Controlled dietary flavanol-/procyanidin- background, consisting of daily intake for 14 days (day -17 to -4) of a commercially available flavanol-/procyanidin-containing cocoa-based drink (250 mg cocoa flavanols; 40 mg of (−)-epicatechin) followed by a 4-day period (day -4 to 0) of a low-flavanol diet.

Other: (−)-[2-14C]epicatechin intake
Single oral intake of an aqueous solution of a mixture of non-radiolabeled (−)-epicatechin and a single-carbon-14 radiolabeled (−)-[2-14C]epicatechin. The target amount of EC delivered with test drink will be 60 mg, 58.5 mg of which consist of non-radiolabled EC and 1.54 mg (300 µCi) consist of (−)-[2-14C]epicatechin.
Other Names:
  • (−)-cis-3,3',4',5,7-Pentahydroxyflavane
  • (2R,3R) - 2- (3,4- Dihydroxyphenyl) - 3,4- dihydro- 1(2H) - benzopyran- 3,5,7- triol




Primary Outcome Measures :
  1. Change in levels of (-)-[2-14C]epicatechin-derived radioactivity in blood, plasma, urine, and feces; [ Time Frame: 0 (prior to the ingestion of (-)-[2-14C]epicatechin), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours postdose, and at every subsequent 24 hour timepoint up to 240 h or until volunteers meet discharge criteria ]

Secondary Outcome Measures :
  1. Composite of pharmacokinetic (PK) parameters of total (-)-[2-14C]epicatechin-derived radioactivity levels in plasma, urine and feces. [ Time Frame: 0 (prior to the ingestion of (-)-[2-14C]epicatechin) up to 240 h or untill volunteers meet discharge criteria ]
    PK parameters: Cmax: maximum observed concentration in plasma; tmax: time to maximum concentration in plasma; AUC0-t: area under the plasma radioactivity-time curve from hour 0 to the last measurable concentration in plasma; AUC0-∞: area under the plasma concentration-time curve extrapolated to infinity; λZ: apparent terminal elimination rate constant in plasma; t1/2: apparent terminal elimination half-life in plasma; CL/F: systemic clearance; Vd/F: apparent volume of distribution; CLR: renal clearance; Aeu(0-t): cumulative amount excreted in the urine over each sampling interval and the total interval examined; Aef(0-t): Cumulative amount excreted in the feces over each sampling interval and the total interval examined.

  2. Composite of pharmacokinetic (PK) parameters of individual (-)-[2-14C]epicatechin metabolites in plasma and urine [ Time Frame: 0 (prior to the ingestion of (-)-[2-14C]epicatechin) up to 240 h or untill volunteers meet discharge criteria ]

    PK parameters of each (-)-epicatechin metabolite:

    Cmax: maximum observed concentration in plasma; tmax: time to maximum concentration in plasma; AUC0-t: area under the plasma concentration-time curve from hour 0 to the last measurable concentration in plasma; AUC0-∞: area under the plasma concentration-time curve extrapolated to infinity; λZ: apparent terminal elimination rate constant in plasma; t1/2: apparent terminal elimination half-life in plasma; CL/F: systemic clearance; Vd/F apparent volume of distribution; CLR: renal clearance; Aeu(0-t): cumulative amount excreted in the urine over each sampling interval and the total interval examined.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria1.

  1. males, in good health, between 18 and 50 years of age and between 60 and 100 kg;
  2. body mass index (BMI) between 19 and 30 kg/m2.
  3. clinical laboratory evaluations (including clinical chemistry [fasted at least 10 hours], hematology, and urinalysis) within the reference range for the testing laboratory, unless deemed not clinically significant by the Investigator;
  4. negative hepatitis panel (including hepatitis B surface antigen [HbsAg] and hepatitis C virus antibody [anti-HCV]) and human immunodeficiency virus (HIV) antibody screens;
  5. a minimum of 1 bowel movement per day.

Exclusion Criteria:

  1. history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders;
  2. allergies to peanuts, nuts, or other foods;
  3. lactose intolerance;
  4. history of stomach or intestinal surgery, except that appendectomy or hernia were allowed;
  5. history of alcoholism or drug addiction within 1 year prior to study entry (ie, at Screening);
  6. use of any tobacco products (including cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum) within 6 months prior to study entry;
  7. use of any agents (excluding those provided as part of this study procedure) affecting the liver enzymes;
  8. use of aspirin-containing drugs and any other over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) during the study, unless deemed acceptable by the Investigator;
  9. use of any alcohol-containing or caffeine-containing products/medications within 72 hours prior to (-)-[2-14C]epicatechin ingestion;
  10. regular consumption of more than 2 alcoholic drinks per day;
  11. vegans, vegetarians and/or anyone who consumed less than 1 to 2 servings of fruits and or vegetables per day;
  12. participation in more than one other radiolabeled investigational study drug trial within 12 months prior to study entry or exposure to significant radiation within 12 months prior to study entry;

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): NCT01969994


Locations
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United States, Wisconsin
Covance Clinical Pharmacology Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
The Institutes for Pharmaceutical Discovery, LLC
Covance
Mars, Inc.
Investigators
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Principal Investigator: Christine L Hale, MD Covance Clinical Pharmacology Inc.
Study Director: Michael Fare IPD, LLC
Study Director: Javier I Ottaviani, Ph.D. Mars, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Institutes for Pharmaceutical Discovery, LLC
ClinicalTrials.gov Identifier: NCT01969994     History of Changes
Other Study ID Numbers: 8215022
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013
Keywords provided by The Institutes for Pharmaceutical Discovery, LLC:
Epicatechin
Flavanols
Procyanidins
Polyphenols
Phytonutrients
AMDE
Antioxidants
Additional relevant MeSH terms:
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Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs