Clinical trial NCT02584946: Avenanthramides and Exercise
Official title: Effect of Avenanthramides Supplement on Exercise-induced Physiological and Psychological Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avenanthramides
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2015-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean and SD of plasma concentrations of Creatine Kinase
timeFrame: 0-72 hours
Secondary outcomes:
measure: Mean and SD of plasma concentrations of TNF-α
timeFrame: 0-72 hours
measure: Mean and SD of plasma concentrations of IL-6
timeFrame: 0-72 hours
measure: Mean and SD of plasma concentrations of ICAM-1, VCAM-1, NF-κB (P65), NRB, NF-κB binding to DNA, 4-Hydroxynenenol, F2-isoprostane
timeFrame: 0-72 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Li Li Ji, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang T, Zhao T, Zhang Y, Liu T, Gagnon G, Ebrahim J, Johnson J, Chu YF, Ji LL. Avenanthramide supplementation reduces eccentric exercise-induced inflammation in young men and women. J Int Soc Sports Nutr. 2020 Jul 25;17(1):41. doi: 10.1186/s12970-020-00368-3.