Avenanthramides Clinical Trial
Official title:
Effect of Avenanthramides Supplement on Exercise-induced Physiological and Psychological Changes
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 |
Verified date | March 2021 |
Source | PepsiCo Global R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
PepsiCo Global R&D |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02415374 -
Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
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N/A |