Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Study Overview
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Brief Summary
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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.

Official Title
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Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Conditions
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Bioavailability, Metabolism, Avenanthramides

Intervention / Treatment
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* Other: Avenanthramides


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Low-AVA oat flour cookies<br>Three low-AVA oat flour cookies | Other: Avenanthramides<br>* 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).<br>|
| Experimental: High-AVA oat flour cookies<br>Three high-AVA cookies | Other: Avenanthramides<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |