NCT04912921

Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammation
• COVID19

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	palmitoylethanolamide	4 tablets taken daily (2 in the am and 2 in the pm)
DIETARY_SUPPLEMENT	Placebo	4 tablets taken daily (2 in am and 2 in pm)
DIETARY_SUPPLEMENT	Curcumin	500 mg HydroCurc® twice a day
DIETARY_SUPPLEMENT	Control (microcrystalline cellulose)	2 tablets taken daily

Timeline

• Start date: 2020-10-20
• Primary completion: 2022-05-15
• Completion: 2022-05-15
• First posted: 2021-06-03
• Last updated: 2023-03-08

Locations

1 site across 1 country: United States