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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

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".

Condition or disease Intervention/treatment Phase
Bioavailability Metabolism Avenanthramides Other: Avenanthramides Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
Actual Study Start Date : January 5, 2015
Actual Primary Completion Date : July 15, 2015
Actual Study Completion Date : July 15, 2015

Arm Intervention/treatment
Placebo Comparator: Low-AVA oat flour cookies
Three low-AVA oat flour cookies
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).

Experimental: High-AVA oat flour cookies
Three high-AVA cookies
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).




Primary Outcome Measures :
  1. iAUC for each AVA [ Time Frame: 0-10 hours ]
  2. Cmax for each AVA [ Time Frame: 0-10 hours ]
  3. Tmax for each AVA [ Time Frame: 0-10 hours ]
  4. T1/2 for each AVA [ Time Frame: 0-10 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02415374


Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Li Li Ji, PhD School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT02415374    
Other Study ID Numbers: PEP-1314
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No