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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| palmitoylethanolamide | Experimental | Levagen |
|
| Placebo | Placebo Comparator | microcrystalline cellulose |
|
| HydroCurc | Experimental | curcumin |
|
| Control | Placebo Comparator | microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palmitoylethanolamide | Dietary Supplement | 4 tablets taken daily (2 in the am and 2 in the pm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| IL6 concentration | interleukin-6 | change from baseline at day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| serum CRP concentration | C-reactive protein (high sensitivity) | change from baseline at day 28 |
| serum ferritin concentration | serum ferritin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Biomedical Collaborative | Phoenix | Arizona | 85004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36084236 | Derived | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
| C109691 | microcrystalline cellulose |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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double-blind, randomized, controlled trial
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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
| Placebo | Dietary Supplement | 4 tablets taken daily (2 in am and 2 in pm) |
|
|
| Curcumin | Dietary Supplement | 500 mg HydroCurc® twice a day |
|
|
| Control (microcrystalline cellulose) | Dietary Supplement | 2 tablets taken daily |
|
|
| 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 |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |