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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02584946
Other study ID # PEP-1513
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2016
Est. completion date July 5, 2016

Study information

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

Clinical Trial Summary

The aim of the proposed study is to examine whether long-term dietary supplementation (8 weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among human subjects.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 5, 2016
Est. primary completion date July 5, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: 1. Male and female non-obese subjects (18kg/M2<BMI<28kg/M2) (age 20-45 years) will be recruited from the Twin Cities community. All participants will sign informed consent approved by UMN-IRB and are willing to avoid oat consumption and rigorous physical activity the day prior to and through test and to consume a low-polyphenol diet for 1 week prior to the study. The foods rich in polyphenols include all berries, apples, pears, citrus fruits, fruit juices, onions, chocolate, wine, coffee, tea, beans, nuts, soy products and most spices Exclusion Criteria: 1. Presence of GI conditions that interfere with absorption; 2. Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders; 3. Major trauma or surgery within 3 months of visit; 4. Cancer in the prior 2 years; 5. Allergic to oat products; 6. Women who are pregnant or lactating; 7. Smoking; 8. Drinking alcohol >5 drinks/week; 9. Using nutraceuticals; 10. Blood pressure medication; 11. NSAID (>800 mg ibuprofen/week) 12. Vitamin supplementation 13. Anticoagulants or hypoglycemic drugs 14. Oat products consumption and rigorous physical activity the day before the test and consumption of a high-polyphenol diet in week prior to the test. 15. Moderate-intensity cardiorespiratory exercise training for =30 min•d-1 on =5 d•wk-1 for a total of =150 min•wk-1, vigorous-intensity cardiorespiratory exercise training for =20 min•d-1 on =3 d•wk-1 (=75 min•wk-1), or a combination of moderate- and vigorous-intensity exercise to achieve a total energy expenditure of =500-1000 MET•min•wk-1

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Avenanthramides
AVAs are a group of diphenolic acids that are found only in oats (Avena sativa).

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 Mean and SD of plasma concentrations of Creatine Kinase 0-72 hours
Secondary Mean and SD of plasma concentrations of TNF-a 0-72 hours
Secondary Mean and SD of plasma concentrations of IL-6 0-72 hours
Secondary Mean and SD of plasma concentrations of ICAM-1, VCAM-1, NF-?B (P65), NRB, NF-?B binding to DNA, 4-Hydroxynenenol, F2-isoprostane 0-72 hours
See also
  Status Clinical Trial Phase
Completed NCT02415374 - Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical N/A