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

Not Applicable

Completed

• Conditions: Inflammation; COVID19
• Interventions: Dietary Supplement: Control (microcrystalline cellulose); Dietary Supplement: Curcumin; Dietary Supplement: Placebo; Dietary Supplement: palmitoylethanolamide

• Registration Number: NCT04912921
• Lead Sponsor: Arizona State University

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 Timeline

• Study First Submitted: 2020-10-15
• Study Start: 2020-10-20
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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
• BMI >40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control (microcrystalline cellulose)	microcrystalline cellulose
HydroCurc	Curcumin	curcumin
Placebo	Placebo	microcrystalline cellulose
palmitoylethanolamide	palmitoylethanolamide	Levagen

Primary Outcome Measures

Name	Time	Method
IL6 concentration	change from baseline at day 28	interleukin-6

Secondary Outcome Measures

Name	Time	Method
serum CRP concentration	change from baseline at day 28	C-reactive protein (high sensitivity)
serum ferritin concentration	change from baseline at day 28	serum ferritin
serum NFk-beta concentration	change from baseline at day 28	nuclear factor kappa-light-chain-enhancer of activated B cells
serum white blood cell differential	change from baseline at day 28	white blood cell differential
serum p-selectin concentration	change from baseline at day 28	cell adhesion molecule
serum ICAM concentration	change from baseline at day 28	Intercellular Adhesion Molecule 1

Trial Locations

Locations (1)

Arizona Biomedical Collaborative; 🇺🇸 Phoenix, Arizona, United States