Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms of upper respiratory tract infection (URTI) in an Adult Population A double blind, randomised controlled trial Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms of upper respiratory tract infection (URTI) in an Adult Population A double blind, randomised controlled trial Study Aim: To assess the effectiveness of PEA for reducing incidence and severity of URTI symptoms and for promoting immune-balancing metabolite and cellular profiles compared to a placebo in healthy adults. Site: This work will be conducted at Arizona State University in the Phoenix metropolitan area as part of a multi-center study sponsored by Gencor Pacific. The College of Health Solutions (CHS) and The Biodesign Institute at Arizona State University are committed to translating scientific health research and discovery into practice by bringing together researchers, faculty, students and community partners to work on specific health challenges. Study Description: The protocol was prepared by Dr. David Briskey, a Research Fellow at the University of Queensland, Australia. In brief, up to 400 healthy adults (18-65 y) will be recruited from the Arizona State University campus community. We will target adults at higher risk for COVID-19/respiratory tract infections including healthcare staff, individuals with obesity (BMI 30-40 kg/m2) or type 2 diabetes, people of color, and those = 60 years of age. Participants will be recruited via online advertisement and social media. Once enrolled, participants will be randomly allocated to the placebo group (CON, maltodextrin opaque capsule identical in appearance to the test product) or the PEA group (600 mg; presented as 150 mg capsules) and instructed to consume four capsules daily. All participants will receive a journal to record respiratory tract symptoms daily for 16 weeks using the validated WURSS-21 questionnaire. Participants will be invited to provide a blood sample at the start of the trial (baseline) and at trial week 16 (end of trial). The target n for blood sampling is at minimum 50 participants from each arm of the trial. If participants report flu-like symptoms during the 16-week trial, they will be asked to submit to testing for COVID-19 and the seasonal flu (testing conducted by the Arizona State University free of charge for employees and students) and to provide these results to study investigators. Anthropometrics, health history, diet, and physical activity information are collected at baseline. The incidence and duration of URTI symptoms are tabulated from journals collected at four-week intervals. Fasting blood samples at baseline and week 16 will be collected by a trained professional at the CHS research clinic, immediately processed, and frozen for later analyses. A subset of blood samples will be analyzed for inflammatory markers, metabolite profiles, and immune cell profiles (to be used to compare differences between treatment arms and for computational modeling). Some in vitro analyses will be conducted to examine the mechanistic action of PEA in cell-virus interactions. Additional study details are outlined in the protocol prepared by Dr. Briskey. Timeline: The trial is anticipated to start in Oct 2020. (The start is contingent on University approval to resume in-person human subject research amid the COVID-19 pandemic.) Following IRB approval, study recruitment will begin in Nov/Dec with 50 participants enrolled by the end of Dec 2020. Up to 350 participants will be enrolled by Mar 2021. The trial is anticipated to be completed by Jun 2021. The incidence and duration of URTI symptoms will be tabulated and analyzed by Aug 2021. Blood analyses are expected to be completed by Sep 2021. Expected results: Based on previous literature demonstrating the efficacy of PEA for reducing URTI, we anticipate a reduced incidence and duration of URTI symptoms in the test arm compared to placebo. Additionally, we anticipate that inflammatory markers, metabolite profiles, and immune cell function will portray a more balanced immune reaction in the test arm compared to placebo.
|Effective start/end date||10/1/20 → 9/30/22|
- INDUSTRY: Domestic Company: $264,084.00
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