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Polyphenol

Avenanthramide for Inflammation (AvenActive Trial)

Phase 1 & 2

Recruiting

Led By Jean-Claude Tardif, MD

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository) If the subject has a partner of childbearing potential, he and/or his partner must agree to use two acceptable birth control methods.

- Subject is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 6 months prior to the first study drug administration)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from drug administration up to 24 hours after the last dose

Awards & highlights

AvenActive Trial Summary

This trial will test the safety and tolerability of avenanthramide, a compound found in oats, and its effects on inflammation biomarkers.

Who is the study for?

Healthy adults or those with a larger waist and low-grade inflammation can join this trial. They must not smoke, use drugs, or have significant health issues. Women of childbearing age should use effective birth control, while men agree to contraception and no sperm donation for 90 days post-trial.Check my eligibility

What is being tested?

The trial is testing Avenanthramide (AVA), a compound from oats thought to reduce inflammation. Participants will take either AVA or a placebo in single or multiple doses to check safety, tolerability, and how the body processes it.See study design

What are the potential side effects?

Specific side effects aren't listed but generally could include reactions at the dose site, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue, allergic reactions if sensitive to ingredients.

AvenActive Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My partner and I agree to use two forms of birth control if she can have children.

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I cannot have children because I had a vasectomy over 6 months ago.

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My waist is at least 100 cm if I'm a man, or 85 cm if I'm a woman.

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I am between 18 and 60 years old.

AvenActive Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after the last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in ECG parameters (Safety and Tolerability)

Change in laboratory parameters (general biochemistry)

Change in laboratory parameters (hematology)

+3 more

Secondary outcome measures

The change in Pharmacokinetics

AvenActive Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Avenanthramide tablet single oral doseActive Control1 Intervention

adaptive dose levels

Group II: Avenanthramide tablet multiple oral doseActive Control1 Intervention

adaptive dose levels

Group III: Placebo to match Avenanthramide tablet single oral dosePlacebo Group1 Intervention

adaptive dose levels

Group IV: Placebo to match Avenanthramide tablet multiple oral dosePlacebo Group1 Intervention

adaptive dose levels

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ceapro Inc.UNKNOWN

1 Previous Clinical Trials

263 Total Patients Enrolled

The Montreal Health Innovations Coordinating Center (MHICC)OTHER

13 Previous Clinical Trials

10,790 Total Patients Enrolled

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

68,723 Total Patients Enrolled

8 Trials studying Inflammation

581 Patients Enrolled for Inflammation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants meet to qualify for this experiment?

"Eligibility to enter this clinical trial requires one to have inflammation and be between 18-60 years of age. The study is currently recruiting 96 participants."

Answered by AI

Does this research protocol permit participants who are aged sixty or above?

"To be considered for this study, patients must fall between the age of 18 and 60. For those under 18 or over 65 years old, there are 35 separate trials available and 263 additional ones respectively."

Answered by AI

Are there any vacancies available for participants in this trial?

"According to records on clinicaltrials.gov, the trial is not currently recruiting and was last updated on October 24th 2023. Nonetheless, there are 353 other medical studies actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single and Multiple Ascending Oral Doses of Avenanthramide

2023. "Single and Multiple Ascending Oral Doses of Avenanthramide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06101784.