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Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02415374
Enrollment
16
Registered
2015-04-14
Start date
2015-01-05
Completion date
2015-07-15
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avenanthramides, Bioavailability, Metabolism

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.

Interventions

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).

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frame
iAUC for each AVA0-10 hours
Cmax for each AVA0-10 hours
Tmax for each AVA0-10 hours
T1/2 for each AVA0-10 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026