Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Not Applicable

Completed

• Conditions: Metabolism; Avenanthramides; Bioavailability
• Interventions: Other: Avenanthramides

• Registration Number: NCT02415374
• Lead Sponsor: 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".

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-05
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Primary Completion: 2015-07-15
• Study Completion: 2015-07-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low-AVA oat flour cookies	Avenanthramides	Three low-AVA oat flour cookies
High-AVA oat flour cookies	Avenanthramides	Three high-AVA cookies

Primary Outcome Measures

Name	Time	Method
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