CClinicalTrials.gg
CompletedNCT02584946Updated Mar 10, 2021

Avenanthramides and Exercise

An interventional study of Avenanthramides in Avenanthramides, sponsored by PepsiCo Global R&D. Completed. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-10.

Sponsored by PepsiCo Global R&D · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Avenanthramides
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    Low-AVA oat flour cookies

    Other: Avenanthramides

  • Experimental
    High-AVA oat flour cookies

    Other: Avenanthramides

Interventions

  • OtherAvenanthramides

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32711519 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02584946
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Oct 23, 2015
Start date
Mar 2, 2016
Primary completion
Jul 5, 2016
Completion
Jul 5, 2016
Last update
Mar 10, 2021

Study contacts

Li Li Ji, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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