BioavailabilityNCT02415374
Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
A study testing Avenanthramides in people with Bioavailability and Metabolism, run by PepsiCo Global R&D.
Trial summary
The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Metabolism, Avenanthramides
- What is being tested?
- Avenanthramides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2015to 15 Jul 2015
- 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
- Male and female non-obese subjects (18kg/M2<BMI<28kg/M2)
- Age 20-45 years)
- Sign an informed consent form approved by UMN-IRB
- Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study
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 16Show 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 the day before the test;
- Rigorous physical activity the day before the test;
- Consumption of a high-flavonoid diet in the week prior to the test.
About this study
The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".
- Conditions
- Bioavailability, Metabolism, 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). In this study, each dietary group of subjects will receive three cookies made with oat flour containing high-AVA (H-AVA, 229.56 mg/kg) and low-AVA (L-AVA, 32.69 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| Low-AVA oat flour cookies | Placebo comparator | Three low-AVA oat flour cookies Receives: Other: Avenanthramides |
| High-AVA oat flour cookies | Experimental | Three high-AVA cookies Receives: Other: Avenanthramides |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC for each AVA
Measured: 0-10 hours
Cmax for each AVA
Measured: 0-10 hours
Tmax for each AVA
Measured: 0-10 hours
T1/2 for each AVA
Measured: 0-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start5 Jan 2015
- Primary completion15 Jul 2015
- Study completion15 Jul 2015
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 BioavailabilityStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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, School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415374
- Sponsor's protocol ID
- PEP-1314
- Status last verified
- Mar 2021
- First submitted
- 6 Apr 2015
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang T, Shao J, Gao Y, Chen C, Yao D, Chu YF, Johnson J, Kang C, Yeo D, Ji LL. Absorption and Elimination of Oat Avenanthramides in Humans after Acute Consumption of Oat Cookies. Oxid Med Cell Longev. 2017;2017:2056705. doi: 10.1155/2017/2056705. Epub 2017 Dec 21.
PubMed 29430278
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
- Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
- ClinicalTrials.gov ID
- NCT02415374
- Acronym / sponsor ID
- PEP-1314
- Conditions
- Bioavailability, Metabolism, Avenanthramides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 14 Apr 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 purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-AVA oat flour cookies | Placebo comparator | Other: AvenanthramidesThree low-AVA oat flour cookies |
| High-AVA oat flour cookies | Experimental | Other: AvenanthramidesThree high-AVA cookies |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female non-obese subjects (18kg/M2<BMI<28kg/M2)
- Age 20-45 years)
- Sign an informed consent form approved by UMN-IRB
- Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study
Key exclusion criteria (16 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). In this study, each dietary group of subjects will receive three cookies made with oat flour containing high-AVA (H-AVA, 229.56 mg/kg) and low-AVA (L-AVA, 32.69 mg/kg). | Other | High-AVA oat flour cookies, Low-AVA oat flour cookies |
Primary outcome
iAUC for each AVA
Time frame: 0-10 hours
Cmax for each AVA
Time frame: 0-10 hours
Tmax for each AVA
Time frame: 0-10 hours
T1/2 for each AVA
Time frame: 0-10 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 29430278Zhang T, Shao J, Gao Y, Chen C, Yao D, Chu YF, Johnson J, Kang C, Yeo D, Ji LL. Absorption and Elimination of Oat Avenanthramides in Humans after Acute Consumption of Oat Cookies. Oxid Med Cell Longev. 2017;2017:2056705. doi: 10.1155/2017/2056705. Epub 2017 Dec 21.
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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
School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455
Questions about this trial
What is this clinical trial studying?
A study testing Avenanthramides in people with Bioavailability and Metabolism, 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 4 inclusion and 16 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?
iAUC for each AVA (time frame: 0-10 hours). The study lists 4 primary outcomes in all. 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 NCT02415374, 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.