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

Purpose

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)

Conditions

  • Inflammation
  • COVID19

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible 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 - BMI >40

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
double-blind, randomized, controlled trial
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

Arm Groups

ArmDescriptionAssigned Intervention
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
Experimental
HydroCurc 		curcumin
  • Dietary Supplement: Curcumin
    500 mg HydroCurc® twice a day
    Other names:
    • Hydrocurc
Placebo Comparator
Control 		microcrystalline cellulose
  • Dietary Supplement: Control (microcrystalline cellulose)
    2 tablets taken daily
    Other names:
    • microcrystalline cellulose

Recruiting Locations

More Details

NCT ID
NCT04912921
Status
Completed
Sponsor
Arizona State University

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.