Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Metabolism Clinical Trial

Official title:

Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415374
• Other study ID #: PEP-1314
• Status: Completed
• Phase: N/A
• Start date: January 5, 2015
• Est. completion date: July 15, 2015

Study information

• Verified date: March 2021
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 15, 2015
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avenanthramides
• Bioavailability
• Metabolism

Intervention

Other:
• Avenanthramides
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iAUC for each AVA		0-10 hours
Primary	Cmax for each AVA		0-10 hours
Primary	Tmax for each AVA		0-10 hours
Primary	T1/2 for each AVA		0-10 hours