NCT05017428

Absorption and Digestion Kinetics of Human Metabolites

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Postprandial Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Spermidine	Spermidine in the form of a 0.1% spermidine wheat germ extract
DIETARY_SUPPLEMENT	Nicotinamide	Nicotinamide given as niacinamide
DIETARY_SUPPLEMENT	PEA	Palmitoylethanolamide given at 98% purity
DIETARY_SUPPLEMENT	OEA	Oleoylehtanolamide given at 90% purity
DIETARY_SUPPLEMENT	Wheat Flour	Wheat flour given as a placebo control

Timeline

• Start date: 2021-04-08
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2021-08-23
• Last updated: 2021-08-23

Locations

1 site across 1 country: United States