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OpenTrials
Completed

NCT Number: NCT02415374

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".

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avenanthramides

Other

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).

Primary outcomes

  1. iAUC for each AVA

    Time frame: 0-10 hours

  2. Cmax for each AVA

    Time frame: 0-10 hours

  3. Tmax for each AVA

    Time frame: 0-10 hours

  4. T1/2 for each AVA

    Time frame: 0-10 hours

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2015
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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