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

NCT04912921 | Completed

• 1 other identifier: STUDY00012462
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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)

Conditions

Inflammation; COVID19

Keywords

palmitoylethanolamide; curcumin

Outcome Measures

Primary Outcomes (1)

• IL6 concentration

  interleukin-6

  change from baseline at day 28

Secondary Outcomes (6)

• serum CRP concentration

  change from baseline at day 28

• serum ferritin concentration

  change from baseline at day 28

• serum ICAM concentration

  change from baseline at day 28

• serum NFk-beta concentration

  change from baseline at day 28

• serum white blood cell differential

  change from baseline at day 28

Study Arms (4)

palmitoylethanolamide

EXPERIMENTAL

Levagen

Dietary Supplement: palmitoylethanolamide

Placebo

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: Placebo

HydroCurc

EXPERIMENTAL

curcumin

Dietary Supplement: Curcumin

Control

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: Control (microcrystalline cellulose)

Interventions

palmitoylethanolamide DIETARY_SUPPLEMENT

4 tablets taken daily (2 in the am and 2 in the pm)

Also known as: Levagen

palmitoylethanolamide

Placebo DIETARY_SUPPLEMENT

4 tablets taken daily (2 in am and 2 in pm)

Also known as: microcrystalline cellulose

Placebo

Curcumin DIETARY_SUPPLEMENT

500 mg HydroCurc® twice a day

Also known as: Hydrocurc

HydroCurc

Control (microcrystalline cellulose) DIETARY_SUPPLEMENT

2 tablets taken daily

Also known as: microcrystalline cellulose

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females 18-65 years old
• Generally healthy
• Able to provide informed consent
• Recent positive COVID-19 test (per RT-PCR Test)\*

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• 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.

  PMID: 36084236 DERIVED

MeSH Terms

Conditions

Inflammation; COVID-19

Interventions

palmidrol; microcrystalline cellulose; Curcumin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, controlled trial

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: June 3, 2021
• Study Start: October 20, 2020
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)