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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)
Must not have
Presence of significant gastrointestinal (GI) conditions that interfere with absorption
Regular use of nutraceuticals such as resveratrol, immune boosters, glucosamine, chondroitin, Coenzyme Q10 supplementation in the 28 days 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
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a stomach or intestine condition that affects how my body absorbs medicine.
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I have not taken supplements like resveratrol or CoQ10 in the last 28 days.
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I am not pregnant or breastfeeding.
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I have been diagnosed with Gilbert syndrome.
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I haven't had cancer treatment in the last year, except for basal cell carcinoma.
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I am not allergic to any ingredients in the trial medication.
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I have had tuberculosis or been in close contact with someone who has.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in ECG parameters (Safety and Tolerability)
Change in laboratory parameters (general biochemistry)
Change in laboratory parameters (hematology)
+3 moreSecondary study objectives
The change in Pharmacokinetics
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
10,790 Total Patients Enrolled
Ceapro Inc.UNKNOWN
1 Previous Clinical Trials
263 Total Patients Enrolled
Montreal Heart InstituteLead Sponsor
123 Previous Clinical Trials
85,270 Total Patients Enrolled
Jean-Claude Tardif, MDPrincipal InvestigatorMontreal Heart Institute
15 Previous Clinical Trials
18,584 Total Patients Enrolled