Arizona Biomedical Collaborative
Phoenix, Arizona, 85004, United States
NCT Number: NCT04912921
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)
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4 tablets taken daily (2 in the am and 2 in the pm)
Other names: Levagen
4 tablets taken daily (2 in am and 2 in pm)
Other names: microcrystalline cellulose
500 mg HydroCurc® twice a day
Other names: Hydrocurc
2 tablets taken daily
Other names: microcrystalline cellulose
Time frame: change from baseline at day 28
interleukin-6
Time frame: change from baseline at day 28
C-reactive protein (high sensitivity)
Time frame: change from baseline at day 28
serum ferritin
Time frame: change from baseline at day 28
Intercellular Adhesion Molecule 1
Time frame: change from baseline at day 28
nuclear factor kappa-light-chain-enhancer of activated B cells
Time frame: change from baseline at day 28
white blood cell differential
Time frame: change from baseline at day 28
cell adhesion molecule
Arizona State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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