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Mechanisms of Palmitoylethanolamide (PEA) to Alter Pain Sensitivity in Knee Osteoarthritis

NCT05406726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-11-05

No results posted yet for this study

Summary

The purposes of this 1-year proof of feasibility and acceptability pilot study are twofold. First to determine if participants with knee osteoarthritis (KOA) will comply with taking palmitoylethanolamide (PEA) dietary supplement for 6 weeks and adhere to taking it as directed. Second is to gain preliminary data to elucidate mechanisms (protein signatures, inflammatory markers and neurobiological signaling pathways) by which PEA, a lipid-based endocannabinoid, works to alter pain sensitivity in adults with KOA. In the simplest terms possible, we need to provide evidence that PEA changes the protein signature in order to provide evidence to establish mechanism.

Conditions

  • Osteoarthritis, Knee

Interventions

DIETARY_SUPPLEMENT

palmitoylethanolamide

palmitoylethanolamide is an lipid based endocannabinoid naturally made by the body and is present in several common foods such as eggs

DIETARY_SUPPLEMENT

Placebo

a capsule filled only with maltodextrin will be used as a placebo

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Jennifer Klinedinst, PhD, MPH, RN · University of Maryland, Baltimore

  • Susan Dorsey, PhD, RN · University of Maryland, Baltimore

  • Marc Hochberg, MD, MPH · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-01-02
Completion
2024-01-02

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 NCT05406726 on ClinicalTrials.gov