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Food Intake and Thermogenesis in Men with High Spinal Cord Injury

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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, 2026Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries
Trauma, 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.

Participants will consume a standardized meal (500 grams) with a low nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours

The ad-libitum meal consists of 600-700 g of a standardized control meal one time at all visits. Participants will attend one visit per week for 3 weeks. Each visit is separated by one week and each visit will take approximately 6 hours.
Group II
Experimental
Subjects will be in this group for up to 3 weeks.

Participants will consume a standardized meal (500 grams) with a moderate nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.

The ad-libitum meal consists of 600-700 g of a standardized control meal one time at all visits. Participants will attend one visit per week for 3 weeks. Each visit is separated by one week and each visit will take approximately 6 hours.
Group III
Experimental
Subjects will be in this group for up to 3 weeks.

Participants will consume a standardized meal (500 grams) with a high nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.

The ad-libitum meal consists of 600-700 g of a standardized control meal one time at all visits. Participants will attend one visit per week for 3 weeks. Each visit is separated by one week and each visit will take approximately 6 hours.
Study Objectives
Primary Objectives

Diet-induced thermogenesis (DIT) will be measured using indirect calorimetry. A portable mask-based metabolic system, which will measure expired air to calculate dietary-induced thermogenesis defined as the energy expended above resting and the proportion of meal energy expended postprandially (postprandial kilocalorie (kcal) expended/total meal kcal) where a higher value means more energy is expended.

Satiety will be measured using the Hunger Series Visual Analog Scale (HSVAS), which assesses subjective appetite. Each scale is defined at 0 as "not at all hungry" and 100 as "totally/a lot/very hungry". A sum score will be calculated.

This value will be expressed as a ratio of energy consumed to energy requirements (energy intake/energy requirements x 100) and will be recorded in grams.

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 ParalysisMiami, United StatesSee the location
Recruiting soonOne Study Center
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