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

Arizona State University (ASU)

Status: Completed

Conditions: Inflammation; COVID19

Treatments: Dietary Supplement: Control (microcrystalline cellulose); Dietary Supplement: Placebo; Dietary Supplement: Curcumin; Dietary Supplement: palmitoylethanolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04912921

STUDY00012462

Details and patient eligibility

About

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)

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 4 patient groups, including a placebo group

palmitoylethanolamide

Experimental group

Description:

Levagen

Treatment:

Dietary Supplement: palmitoylethanolamide

Placebo

Placebo Comparator group

Description:

microcrystalline cellulose

Treatment:

Dietary Supplement: Placebo

HydroCurc

Experimental group

Description:

curcumin

Treatment:

Dietary Supplement: Curcumin

Control

Placebo Comparator group

Description:

microcrystalline cellulose

Treatment:

Dietary Supplement: Control (microcrystalline cellulose)