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Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

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ClinicalTrials.gov Identifier: NCT02415374
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Tracking Information
First Submitted Date  ICMJE April 6, 2015
First Posted Date  ICMJE April 14, 2015
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE January 5, 2015
Actual Primary Completion Date July 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
  • iAUC for each AVA [ Time Frame: 0-10 hours ]
  • Cmax for each AVA [ Time Frame: 0-10 hours ]
  • Tmax for each AVA [ Time Frame: 0-10 hours ]
  • T1/2 for each AVA [ Time Frame: 0-10 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
Official Title  ICMJE Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
Brief Summary The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Bioavailability
  • Metabolism
  • Avenanthramides
Intervention  ICMJE Other: Avenanthramides
AVAs are a group of diphenolic acids that are found only in oats (Avena sativa). In this study, each dietary group of subjects will receive three cookies made with oat flour containing high-AVA (H-AVA, 229.56 mg/kg) and low-AVA (L-AVA, 32.69 mg/kg).
Study Arms  ICMJE
  • Placebo Comparator: Low-AVA oat flour cookies
    Three low-AVA oat flour cookies
    Intervention: Other: Avenanthramides
  • Experimental: High-AVA oat flour cookies
    Three high-AVA cookies
    Intervention: Other: Avenanthramides
Publications * Zhang T, Shao J, Gao Y, Chen C, Yao D, Chu YF, Johnson J, Kang C, Yeo D, Ji LL. Absorption and Elimination of Oat Avenanthramides in Humans after Acute Consumption of Oat Cookies. Oxid Med Cell Longev. 2017;2017:2056705. doi: 10.1155/2017/2056705. Epub 2017 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2015)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2015
Actual Primary Completion Date July 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female non-obese subjects (18kg/M2<BMI<28kg/M2)
  • Age 20-45 years)
  • Sign an informed consent form approved by UMN-IRB
  • Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study

Exclusion Criteria:

  • Presence of GI conditions that interfere with absorption;
  • Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders;
  • Major trauma or surgery within 3 months of visit;
  • Cancer in the prior 2 years;
  • Allergic to oat products;
  • Women who are pregnant or lactating;
  • Smoking;
  • Drinking alcohol >5 drinks/week;
  • Using nutraceuticals;
  • Blood pressure medication;
  • NSAID (>800 mg ibuprofen/week);
  • Vitamin supplementation;
  • Anticoagulants or hypoglycemic drugs;
  • Oat products consumption the day before the test;
  • Rigorous physical activity the day before the test;
  • Consumption of a high-flavonoid diet in the week prior to the test.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02415374
Other Study ID Numbers  ICMJE PEP-1314
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PepsiCo Global R&D
Study Sponsor  ICMJE PepsiCo Global R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Li Ji, PhD School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455
PRS Account PepsiCo Global R&D
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP