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Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

PepsiCo logo

PepsiCo

Status

Completed

Conditions

Metabolism
Bioavailability
Avenanthramides

Treatments

Other: Avenanthramides

Study type

Interventional

Funder types

Industry

Identifiers

NCT02415374
PEP-1314

Details and patient eligibility

About

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".

Enrollment

16 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

16 participants in 2 patient groups, including a placebo group

Low-AVA oat flour cookies
Placebo Comparator group
Description:
Three low-AVA oat flour cookies
Treatment:
Other: Avenanthramides
High-AVA oat flour cookies
Experimental group
Description:
Three high-AVA cookies
Treatment:
Other: Avenanthramides

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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