Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

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".

Study Overview

• Status: Completed
• Conditions: Bioavailability; Metabolism; Avenanthramides
• Intervention / Treatment: Other: Avenanthramides

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
iAUC for each AVA	0-10 hours
Cmax for each AVA	0-10 hours
Tmax for each AVA	0-10 hours
T1/2 for each AVA	0-10 hours

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Li Li Ji, PhD, School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2015
• Primary Completion (Actual): July 15, 2015
• Study Completion (Actual): July 15, 2015

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1314

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No