None listed
Conditions
Brief summary
Quercetin is a naturally occurring antioxidant with antiviral and anti-inflammatory activity. It has been shown to reduce many inflammatory pathways that are present in asthma and inhibits the activity of common respiratory viruses that can cause flare-ups in patients with asthma. The benefits of quercetin in clinical trials have been inconsistent and this is likely due to the small amount of quercetin that is absorbed into the bloodstream and the relatively low doses of quercetin used in most clinical trials. Much larger doses of quercetin are likely to be required to attain beneficial clinical effects. We plan to undertake a feasibility study to evaluate whether higher doses of quercetin can attain adequate blood concentrations, and to assess the safety of these high doses. This information will inform the development of a randomised controlled trial of quercetin for the treatment of asthma. This study is a single centre, dose-ranging, open-label study of high dose oral quercetin in adults randomised to receive either 2000 mg daily, or 4000 mg daily in two divided doses. Primary outcome measured is the plasma quercetin level after 6 weeks of high dose supplementation. Secondary outcomes includes change in full blood count, renal function, liver function, c-reactive protein, adherence and adverse events.
Interventions
Arm 1: Oral quercetin 1000mg twice a day for 6 weeks
Arm 2: Oral quercetin 2000mg twice a day for 6 weeks
Adherence to assigned dose of quercetin supplementation will be assessed by returned capsule count at week 2 and 6.
Sponsors
Leon Huang
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age greater than or equal to 18 years 2. Able to provide informed consent 3. Body mass index 18.0 – 35.0 kg/m2
Exclusion criteria
1. Participants with chronic kidney disease with eGFR < 30 2. Participants with evidence of active or suspected cancer and participants having undergone cancer treatment including resection, radiation therapy or chemotherapy within the last 2 years (participants with basal cell carcinoma and squamous cell carcinoma are allowed) 3. Participation in a separate clinical or device trial within 4 weeks of screening 4. Participants currently taking cyclosporine, pravastatin, fexofenadine, and/or midazolam 5. Pregnant or lactating women 6. Allergy to quercetin
Outcome results
None listed