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Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Sponsor
PepsiCo Global R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT02415374
Collaborator
(none)
16
Enrollment
2
Arms
6.3
Actual Duration (Months)

Study Details

Study Description

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
  • Other: Avenanthramides
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 5, 2015
Actual Primary Completion Date :
Jul 15, 2015
Actual Study Completion Date :
Jul 15, 2015

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. iAUC for each AVA [0-10 hours]

  2. Cmax for each AVA [0-10 hours]

  3. Tmax for each AVA [0-10 hours]

  4. T1/2 for each AVA [0-10 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • PepsiCo Global R&D

Investigators

  • Principal Investigator: Li Li Ji, PhD, School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PepsiCo Global R&D
ClinicalTrials.gov Identifier:
NCT02415374
Other Study ID Numbers:
  • PEP-1314
First Posted:
Apr 14, 2015
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 10, 2021