Food Intake and Thermogenesis in High Spinal Cord Injury
NCT ID: NCT07103993
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2026-03-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feeding Regulation in SCI
NCT05406739
Postprandial Lipid Tracer and Exercise in Spinal Cord Injury
NCT03691532
Nutrition Education Program in Spinal Cord Injury (SCI)
NCT05953597
Gut-Brain Neural Coupling in Spinal Cord Injury
NCT07052344
Energetic Response to Feeding and Exercise in SCI
NCT03545867
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low meal condition group
Subjects will be in this group for up to 3 weeks.
Low meal condition
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
Ad-libitum control condition
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.
Moderate meal condition group
Subjects will be in this group for up to 3 weeks.
Moderate meal condition
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.
Ad-libitum control condition
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.
High meal condition group
Subjects will be in this group for up to 3 weeks.
High meal condition
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.
Ad-libitum control condition
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low meal condition
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
Moderate meal condition
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.
High meal condition
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.
Ad-libitum control condition
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men
* Physically inactive (\<150 minutes per week of moderate-vigorous activity intensity for the preceding 3 months)
* Weight stable: body mass ±3 kilograms (kg) for past 3 months
SCI Only
* 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
Exclusion Criteria
* Uncompensated thyroid disease
* Diabetes
* Swallowing or gastrointestinal pathologies
* Allergies or aversions to foods/ingredients
* Prescribed prokinetic, antipsychotic, or anti-obesity agents
SCI Only
* Incomplete SCI AIS C or D
* Ventilator-dependent
18 Years
65 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Craig H. Neilsen Foundation
OTHER
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gary Farkas
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gary J Farkas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20250335
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.