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

COVID19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912921
• Other study ID #: STUDY00012462
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: May 15, 2022

Study information

• Verified date: March 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19
• Inflammation

Intervention

Dietary Supplement:
• palmitoylethanolamide
4 tablets taken daily (2 in the am and 2 in the pm)
• Placebo
4 tablets taken daily (2 in am and 2 in pm)
• Curcumin
500 mg HydroCurc® twice a day
• Control (microcrystalline cellulose)
2 tablets taken daily

Locations

Country	Name	City	State
United States	Arizona Biomedical Collaborative	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL6 concentration	interleukin-6	change from baseline at day 28
Secondary	serum CRP concentration	C-reactive protein (high sensitivity)	change from baseline at day 28
Secondary	serum ferritin concentration	serum ferritin	change from baseline at day 28
Secondary	serum ICAM concentration	Intercellular Adhesion Molecule 1	change from baseline at day 28
Secondary	serum NFk-beta concentration	nuclear factor kappa-light-chain-enhancer of activated B cells	change from baseline at day 28
Secondary	serum white blood cell differential	white blood cell differential	change from baseline at day 28
Secondary	serum p-selectin concentration	cell adhesion molecule	change from baseline at day 28