We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Association Between Body Composition and Pain in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05459207
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Elizabeth Felix, University of Miami

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Pain Inflammatory Response Other: Moderate Fat Meal Other: High Fat Meal Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
Actual Study Start Date : February 20, 2023
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Moderate Fat Meal, Followed by High Fat Meal Group
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
 Other: Moderate Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a normal/moderate fat meal.

Other: High Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a high-fat meal.
Experimental: High Fat Meal, Followed by Moderate Fat Meal Group
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
 Other: Moderate Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a normal/moderate fat meal.

Other: High Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a high-fat meal.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. peak change in Interleukin (IL)-6 [ Time Frame: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion ]
    analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter

  2. peak change in evoked pain sensitivity [ Time Frame: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion ]
    measures of heat pain threshold (degrees Celcius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge


Secondary Outcome Measures :
  1. correlation coefficient between changes in IL-6 and evoked pain sensitivity [ Time Frame: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion ]
    correlation coefficient for relationship between changes in IL-6 and heat pain thresholds across time


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • SCI occurring at least 2 years prior to study entry
  • Neurological level of injury (LOI) between C4 and L2
  • American Spinal Injury Association Impairment Scale (AIS) A-D
  • English-speaking.

Exclusion Criteria:

  • Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
  • Health conditions associated with chronic systemic inflammation unrelated to weight or adiposity (e.g., systemic autoimmune diseases, recurrent or active urinary tract infection, pressure injury > Stage 2)
  • Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture > 15 degrees)
  • Inability to obtain free-flowing blood from a superficial forearm or hand vein
  • Pregnant women
  • Prisoners
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05459207


Contacts
Layout table for location contacts
Contact: Elizabeth Felix, PhD 305-243-4497 efelix@med.miami.edu

Locations
Layout table for location information
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Contact: Elizabeth Felix, PhD    305-243-4497    efelix@med.miami.edu   
Principal Investigator: Elizabeth Felix, PhD         
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Felix, PhD University of Miami
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Elizabeth Felix, Research Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05459207    
Other Study ID Numbers: 20211078
90SCIMS0013 ( Other Grant/Funding Number: National Institute for Disability, Independent Living, and Rehabilitation Research )
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries