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

This is a randomized controlled trial 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).

Study Overview

• Status: Completed
• Conditions: Inflammation; COVID19
• Intervention / Treatment: Dietary supplement: palmitoylethanolamide; Dietary supplement: Placebo

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) 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 this dietary supplement 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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Biomedical Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: palmitoylethanolamide; Levagen	Dietary supplement: palmitoylethanolamide; 4 tablets taken daily (2 in the am and 2 in the pm); Other Names: Levagen
PLACEBO_COMPARATOR: Placebo; microcrystalline cellulose	Dietary supplement: Placebo; 4 tablets taken daily (2 in am and 2 in pm); Other Names: microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL6 concentration	interleukin-6	change from baseline at day 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arizona State University

Publications and helpful links

General Publications

• Fessler SN, Liu L, Chang Y, Yip T, Johnston CS. Palmitoylethanolamide Reduces Proinflammatory Markers in Unvaccinated Adults Recently Diagnosed with COVID-19: A Randomized Controlled Trial. J Nutr. 2022 Oct 6;152(10):2218-2226. doi: 10.1093/jn/nxac154.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2020
• Primary Completion (ACTUAL): May 15, 2022
• Study Completion (ACTUAL): May 15, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (ACTUAL): June 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: palmitoylethanolamide
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Inflammation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Palmidrol
• Other Study ID Numbers: STUDY00012462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No