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Food Intake and Thermogenesis in Men with High Spinal Cord Injury

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Low meal condition

+ Ad-libitum control condition

+ Moderate meal condition

Other
Who is being recruted

Central Nervous System Diseases+3

+ Nervous System Diseases

+ Spinal Cord Diseases

From 18 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorUniversity of Miami
Study ContactGuillermo MederosMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This research study focuses on understanding how food affects heart and metabolic health in men, specifically comparing those with spinal cord injuries to those without. Spinal cord injuries can significantly impact how the body functions, including food digestion and energy use. By studying these effects, researchers hope to gain insights that could lead to better dietary recommendations and improved health outcomes for individuals living with spinal cord injuries. Participants in the study will undergo assessments to measure how their bodies respond to food intake. The study will analyze cardiovascular and metabolic responses to find any differences between those with and without spinal cord injuries. While the study details do not specify the exact procedures or potential risks, the goal is to gather valuable data that could inform future health strategies and interventions.

Official TitleFood Intake and Thermogenesis in High Spinal Cord Injury 
NCT07103993
Principal SponsorUniversity of Miami
Study ContactGuillermo MederosMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesSpinal Cord InjuriesWounds and InjuriesTrauma, Nervous System

Criteria

6 inclusion criteria required to participate
Chronic SCI (≥ 1-year post-injury)

Motor-complete SCI American Spinal Injury Association Impairment Scale (AIS) A and B

T6 injuries and above that can independently feed themselves

Men

Show More Criteria

7 exclusion criteria prevent from participating
Incomplete SCI AIS C or D

Ventilator-dependent

Uncompensated thyroid disease

Diabetes

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will be in this group for up to 3 weeks.

Group II

Experimental
Subjects will be in this group for up to 3 weeks.

Group III

Experimental
Subjects will be in this group for up to 3 weeks.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Miami - Miami Project to Cure Paralysis

Miami, United StatesSee the location
Recruiting soonOne Study Center