NCT02584946CompletedNot Applicable
Effect of Avenanthramides Supplement on Exercise-induced Physiological and Psychological Changes
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PepsiCo Global R&D
- Enrollment
- 24
- Primary Endpoint
- Mean and SD of plasma concentrations of Creatine Kinase
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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;
- •Drinking alcohol >5 drinks/week;
- •Using nutraceuticals;
- •Blood pressure medication;
- •NSAID (>800 mg ibuprofen/week)
- •Vitamin supplementation
- •Anticoagulants or hypoglycemic drugs
- •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.
- •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
Arms & Interventions
Low-AVA oat flour cookies
Placebo Comparator
Intervention: Avenanthramides (Other)
High-AVA oat flour cookies
Experimental
Intervention: Avenanthramides (Other)
Outcomes
Primary Outcomes
Mean and SD of plasma concentrations of Creatine Kinase
Time Frame: 0-72 hours
Secondary Outcomes
- Mean and SD of plasma concentrations of TNF-α(0-72 hours)
- Mean and SD of plasma concentrations of IL-6(0-72 hours)
- Mean and SD of plasma concentrations of ICAM-1, VCAM-1, NF-κB (P65), NRB, NF-κB binding to DNA, 4-Hydroxynenenol, F2-isoprostane(0-72 hours)
Investigators
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