AvenanthramidesNCT02584946

Avenanthramides and Exercise

A study testing Avenanthramides in people with Avenanthramides, run by PepsiCo Global R&D.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Avenanthramides
What is being tested?: Avenanthramides
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: No sites listed yet
Study dates: 2 Mar 2016to 5 Jul 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Show all 15Show fewer

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

About this study

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

Conditions: Avenanthramides
Being tested: Avenanthramides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02584946
Study group	Role	What they receive
Low-AVA oat flour cookies	Placebo comparator	Not described Receives: Other: Avenanthramides
High-AVA oat flour cookies	Experimental	Not described Receives: Other: Avenanthramides

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean and SD of plasma concentrations of Creatine Kinase
Measured: 0-72 hours

Secondary outcomes (3)

Mean and SD of plasma concentrations of TNF-α
Measured: 0-72 hours
Mean and SD of plasma concentrations of IL-6
Measured: 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
Measured: 0-72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20165 Jul 2016

First posted23 Oct 2015 (estimated)
Study start2 Mar 2016
Primary completion5 Jul 2016
Study completion5 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AvenanthramidesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02584946
Sponsor's protocol ID: PEP-1513
Status last verified: Mar 2021
First submitted: 21 Oct 2015
Last updated: 10 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Avenanthramides Supplement on Exercise-induced Physiological and Psychological Changes
ClinicalTrials.gov ID: NCT02584946
Acronym / sponsor ID: PEP-1513
Conditions: Avenanthramides
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PepsiCo Global R&DIndustry (pharma, biotech, devices)
Study start: 2 Mar 2016 (actual)
Primary completion: 5 Jul 2016 (actual)
Study completion: 5 Jul 2016 (actual)
First posted: 23 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Low-AVA oat flour cookies	Placebo comparator	Other: Avenanthramides
High-AVA oat flour cookies	Experimental	Other: Avenanthramides

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AvenanthramidesAVAs are a group of diphenolic acids that are found only in oats (Avena sativa).	Other	High-AVA oat flour cookies, Low-AVA oat flour cookies

Primary outcome

Mean and SD of plasma concentrations of Creatine Kinase
Time frame: 0-72 hours

3 secondary outcomes

Mean and SD of plasma concentrations of TNF-α
Time frame: 0-72 hours
Mean and SD of plasma concentrations of IL-6
Time frame: 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
Time frame: 0-72 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Derived from this study: PubMed 32711519Zhang 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Li Li Ji, PhD principal investigator

University of Minnesota

Questions about this trial

What is this clinical trial studying?

A study testing Avenanthramides in people with Avenanthramides, run by PepsiCo Global R&D.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean and SD of plasma concentrations of Creatine Kinase (time frame: 0-72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.