Meal Conditions for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how different types of meals affect heart and metabolic health in men with and without spinal cord injuries (SCI). Participants will join one of three groups, each trying a different meal condition: high, moderate, or low meal options for up to three weeks. This research targets men who are not very active and have stable weight. Specifically, men with a long-term spinal cord injury that affects movement and who can feed themselves might be suitable candidates. The trial aims to determine how meal type influences health, especially in those with SCI. As an unphased trial, this study offers a unique opportunity to contribute to understanding nutrition's impact on health, particularly for those with SCI.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are prescribed prokinetic, antipsychotic, or anti-obesity medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that different meal plans affect people with spinal cord injury (SCI) in various ways. One study on high-fat meals found that short-term high-fat diets did not significantly change inflammation levels, although some other health markers worsened. This suggests that while some changes occur, they might not be serious or harmful in the short term.
For low-fat meals, studies suggest that a balanced diet with the right mix of carbohydrates, proteins, and fats is important. People with SCI often experience energy imbalances, and good nutrition can help manage these issues safely.
Regarding moderate meals, evidence shows that working with a dietitian can improve health for SCI patients. This indicates that a balanced meal plan is generally safe and beneficial.
Overall, these meal plans aim to find the best balance for health. They are based on current knowledge about nutrition and SCI and are generally considered safe. However, individual responses can vary, so healthcare professionals must monitor participants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how different meal conditions—high, moderate, and low—impact individuals with spinal cord injuries. Unlike traditional treatments that focus on medication or physical therapy, this approach examines the role of nutrition and meal sizes in recovery and overall well-being. By understanding the effects of various meal conditions, researchers hope to uncover new insights that could lead to innovative nutritional strategies, potentially improving the quality of life for those with spinal cord injuries.
What evidence suggests that this trial's meal conditions could be effective for spinal cord injury?
This trial will compare different meal conditions for individuals with spinal cord injuries (SCI). Research has shown that diet plays a crucial role for people with SCI. Participants in the high meal condition group may experience changes in certain health markers after consuming large meals, although inflammation remains largely unchanged. Those in the low meal condition group may benefit from foods with a low-glycemic index to help maintain steady blood sugar levels. Studying medium-sized meals presents challenges, but participants in the moderate meal condition group will help explore how balanced diets can prevent common nutrient deficiencies in SCI. Overall, adjusting meal sizes and types can improve health by managing energy and nutrient intake.23678
Who Is on the Research Team?
Gary J Farkas, PhD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for men with spinal cord injuries (SCI) at T6 or above, who have been stable in their condition for over a year and can feed themselves. It's also open to inactive men without SCI. Participants should not be very active and must have maintained a consistent weight recently.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants are assigned to one of three meal condition groups (Moderate, Low, High) for up to 3 weeks to assess the effects of food on cardiovascular and metabolic health
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Ad-libitum control condition
- High meal condition
- Low meal condition
- Moderate meal condition
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
The Craig H. Neilsen Foundation
Collaborator