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OpenTrials
Completed

NCT Number: NCT02584946

Avenanthramides and Exercise

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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 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

Treatment and study plan

Avenanthramides

Other

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

Primary outcomes

  1. Mean and SD of plasma concentrations of Creatine Kinase

    Time frame: 0-72 hours

Secondary outcomes

  1. Mean and SD of plasma concentrations of TNF-α

    Time frame: 0-72 hours

  2. Mean and SD of plasma concentrations of IL-6

    Time frame: 0-72 hours

  3. Mean and SD of plasma concentrations of ICAM-1, VCAM-1, NF-κB (P65), NRB, NF-κB binding to DNA, 4-Hydroxynenenol, F2-isoprostane

    Time frame: 0-72 hours

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

Effect of Avenanthramides Supplement on Exercise-induced Physiological and Psychological Changes

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2015
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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