High Fat Meal for Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Coral Gables, FL
Pain+2 More
High Fat Meal - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury

Eligible Conditions

  • Pain
  • Inflammatory Responses

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
correlation coefficient between changes in IL-6 and evoked pain sensitivity
peak change in Interleukin (IL)-6
peak change in evoked pain sensitivity

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

High Fat Meal, Followed by Moderate Fat Meal Group
1 of 2
Moderate Fat Meal, Followed by High Fat Meal Group
1 of 2
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: High Fat Meal · No Placebo Group · N/A

High Fat Meal, Followed by Moderate Fat Meal GroupExperimental Group · 2 Interventions: Moderate Fat Meal, High Fat Meal · Intervention Types: Other, Other
Moderate Fat Meal, Followed by High Fat Meal GroupExperimental Group · 2 Interventions: Moderate Fat Meal, High Fat Meal · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Closest Location: University of Miami · Coral Gables, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
2 TrialsResearching Pain
621 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
381,722 Total Patients Enrolled
6 Trials studying Pain
1,150 Patients Enrolled for Pain
Elizabeth Felix, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
98 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a spinal cord injury at least 2 years prior to study entry.
You have a neurological level of injury (LOI) between C4 and L2.
A score of A or B on the AIS Impairment Scale indicates an impairment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.