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Absorption and Digestion Kinetics of Human Metabolites

NCT05017428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-08-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05017428 on ClinicalTrials.gov