AvenanthramidesNCT02584946
Avenanthramides and Exercise
A study testing Avenanthramides in people with Avenanthramides, run by PepsiCo Global R&D.
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;
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- 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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Li Ji, PhD, Principal investigator, University of Minnesota
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.
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
- 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.