Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Arizona State University
- Enrollment
- 115
- Locations
- 2
- Primary Endpoint
- IL6 concentration
Study Overview
Brief Summary
Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)
Detailed Description
Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease and tissue pathology. This research offers a natural, dietary approach to managing inflammation by reducing the mediators of inflammation. The beneficial effects of palmitoylethanolamide (PEA) and for curcumin for reducing inflammation is documented in the research literature. The proposed research will expand this literature in a novel manner. The investigators propose to demonstrate the efficacy of these dietary supplements in individuals from a campus population with robust immune protection - those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic. Since a college population is under many stressors which raise inflammatory profiles during the academic year, and since a college population is exposed to infectious agents on campus, maintaining strong protective immune system following a COVID-19 infection is important.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
Palmitoylethanolamide and placebo tablets are identical in appearance and presented to participant in unlabeled opaque containers by investigators blinded to container content. Curcumin and control tablets are identical in appearance and presented to participant in unlabeled opaque containers by investigators blinded to container content
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and females 18-65 years old
- •Generally healthy
- •Able to provide informed consent
- •Recent positive COVID-19 test (per RT-PCR Test)*
Exclusion Criteria
- •Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma)
- •Serious mood disorders, neurological disorders such as MS, or cognitive damage
- •Active smokers and/or nicotine or drug abuse
- •Active, regular marijuana or other cannabinoid use, other street/recreational drug use
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in active or placebo formula including peanuts, eggs or turmeric
- •Pregnant or lactating woman
- •People medically prescribed to take drugs that would affect the immune and/or the inflammatory response
- •People who have had treatment (last 5 years) for cancer, or chronic use of steroids
Outcomes
Primary Outcomes
IL6 concentration
Time Frame: change from baseline at day 28
interleukin-6
Secondary Outcomes
- serum ICAM concentration(change from baseline at day 28)
- serum CRP concentration(change from baseline at day 28)
- serum ferritin concentration(change from baseline at day 28)
- serum NFk-beta concentration(change from baseline at day 28)
- serum white blood cell differential(change from baseline at day 28)
- serum p-selectin concentration(change from baseline at day 28)