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The Effects of Lipinova on Inflammatory and Proresolving Lipid Mediator Profiles After Orthopedic Surgery

NCT03434236 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-15

No results posted yet for this study

Summary

The aim of this pilot study is to investigate whether pre-operative supplementation with an over the counter dietary supplement containing a fractionated marine lipid concentrate derived from anchovy and sardine oil, Lipinova® (Solutex), improves the inflammatory profile and proresolving capacity in patients undergoing total knee arthroplasty. In addition, the investigators will compare the ability of two different dosing regimens to maximize SPM (Specialized Proresolving Mediators) availability.

Conditions

Interventions

DIETARY_SUPPLEMENT

low dose Lipinova (30 mL daily)

Lipinova is a nutritional supplement containing concentrated n-3 PUFA (EPA and DHA) and metabolites

DIETARY_SUPPLEMENT

Placebo

Placebo will have a similar appearance, smell and taste as the nutritional supplement

DIETARY_SUPPLEMENT

high dose Lipinova (60mL)

Lipinova is a nutritional supplement containing concentrated n-3 PUFA (EPA and DHA) and metabolites

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Mieke Soens, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2018-10-01
Completion
2018-11-01

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Entities

Diseases

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 NCT03434236 on ClinicalTrials.gov