University of California Davis
Davis, California, 95616, United States
NCT Number: NCT05017428
The purpose of this pilot study is to evaluate the effects oral supplementation with four human metabolites (spermidine, nicotinamide, palmitoylethanolamide (PEA), and oleoylethanolamide(OEA)) at varying doses on the circulating blood levels of these metabolites as well as their immediate effects on plasma functionality and postprandial inflammation. 5 young healthy subjects will participate in a four armed study consisting of a Placebo arm and a Low, Medium, and High Dose arm. Subjects will be given a standardized breakfast along with supplementation with either an escalating dose (Low: 1x, Medium: 2x, High: 3x) of a combination of spermidine, nicotinamide, PEA and OEA or a placebo control and a time course of their blood plasma will be collected after supplementation. Plasma samples will be assessed for their concentration of spermidine, nicotinamide, PEA, and OEA as well as their experimental and clinical functionalities including their anti-inflammatory, antioxidant, and cholesterol efflux abilities on primary human macrophage.
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Notify Me20 year–40 year
Male
Interventional
Not applicable
Davis, California, 95616, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spermidine in the form of a 0.1% spermidine wheat germ extract
Other names: Primeadine
Nicotinamide given as niacinamide
Other names: Jarrow Niacinamide
Palmitoylethanolamide given at 98% purity
Other names: Nootropics Depot PEA
Oleoylehtanolamide given at 90% purity
Other names: Riduzone
Wheat flour given as a placebo control
Time frame: 1, 2, and 4 hours after ingestion
Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).
Time frame: 1, 2, and 4 hours after ingestion
Ex vivo assessment of the effects of subject plasma on the secretion of pro-inflammatory cytokine TNF-alpha (pg/mL) by primary human macrophage
University of California, Davis
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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