Dietary Effects for Spinal Cord Injury

Overseen By Gary J Farkas, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Antidiabetics, Antipsychotics, Narcotics, others

Disqualifiers: Diabetes, Gastrointestinal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of meals affect brain and stomach activity in people with and without spinal cord injuries (SCI). Researchers compare two meal conditions: one where participants eat freely (ad-libitum control condition) and another with a specific meal plan (preload condition). The trial seeks adults who are weight-stable, not very active, and can speak and write English easily. It specifically includes individuals with a chronic spinal cord injury (lasting more than a year) who can feed themselves and follow a regular bowel care routine. Those with a spinal cord injury who meet these criteria might be a good match for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how meal types affect individuals with spinal cord injuries.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking medications that can impact appetite, body weight, and/or bowel function, such as certain digestive, pain, and mental health medications.

What prior data suggests that these dietary conditions are safe for participants?

Research has shown that feeding directly into the stomach soon after a spinal cord injury does not clearly cause harm. Studies have found no major safety differences between starting feeding early or later in these patients, suggesting that this approach is generally safe.

As this trial is not in a specific phase, it may still be in the early stages of testing, meaning some safety questions are still being explored.

Participants in this study will try two different meal plans. Current research considers both plans safe, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring dietary effects for spinal cord injury because this approach is non-invasive and focuses on nutritional adjustments, which could offer an easier supplement or alternative to current therapies like physical rehabilitation and medication. Unlike standard treatments that typically target symptoms or aid in physical recovery, the new dietary methods might directly influence the body's healing processes and overall well-being. By examining how different dietary conditions, such as the Pre-load and Ad-libitum meal groups, affect recovery, researchers hope to discover how specific eating patterns can support or enhance traditional treatment outcomes.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that people with spinal cord injuries (SCI) are more likely to become obese and develop heart and metabolism-related diseases. These health issues relate to how the body uses energy from food, which can differ for those with SCI. This trial will compare two dietary approaches: the Pre-load Condition Meal Group and the Ad-libitum Condition Meal Group. Another study examined how eating affects the brain and stomach in people with SCI to better understand the gut-brain connection. That study found that about 17% to 19% of the daily energy intake for people with SCI comes from protein. By studying these dietary factors, researchers aim to improve health outcomes for those with SCI. ^{2 3 6 7 8}

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 adults aged 18-70 who are fluent in English, not physically active, and have maintained their weight recently. It's not for smokers, those on a diet or with dietary restrictions, pregnant/breastfeeding women, prisoners, or people with certain medical conditions like uncontrolled thyroid disease or diabetes.

Inclusion Criteria

Weight-stable (±3 kg) for the preceding 3 months (self-report)

Physically inactive adults not meeting weekly activity guidelines (<150 min/week) for the preceding 3 months (self-report)

Fluent in written and spoken English

Exclusion Criteria

Do not meet the inclusion criteria

Current/regular smoker (defined by Center for Disease Control (CDC)/ National Institute of Health (NIH) as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes either every day or every other day) (self-report)

Currently dieting and/or trying to gain or lose weight

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-load Condition Meal

Participants receive a pre-load meal to assess gut-brain connectivity

2 weeks

Ad-libitum Condition Meal

Participants receive an ad-libitum meal to assess gut-brain connectivity

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ad-libitum control condition
• Preload condition

Trial Overview The study aims to understand how food affects brain and stomach activity in individuals with and without spinal cord injury by comparing two eating conditions: one where participants preload with food and another where they eat as much as they want (ad-libitum).

How Is the Trial Designed?

Group I: Pre-load Condition Meal Group Experimental Treatment 2 Interventions

Participants will be in this group for up to 2 weeks.

Group II: Ad-libitum Condition Meal Group Active Control 1 Intervention

Participants will be in this group for up to 2 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7983636/

Dietetics After Spinal Cord Injury: Current Evidence and ... Farkas et al., Gorgey et al., and Nightingale et al. reported that 17% to 19% of the total daily energy intake came from protein for persons with SCI.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39595730/

Self-Reported Difficulty with and Assistance Needed by ... Individuals with spinal cord injury (SCI) experience an increased risk for obesity and cardiometabolic disease.

3. patlynk.com patlynk.com/trial/NCT07052344

Spinal Cord Injury's Gut-Brain Neural Connection Study This study explores how eating affects the brain and stomach in people who have spinal cord injuries compared to those who do not. It aims to understand the ...

4. researchgate.net researchgate.net/publication/375425918_Reasons_for_meal_termination_eating_frequency_and_typical_meal_context_differ_between_persons_with_and_without_a_spinal_cord_injury

Reasons for meal termination, eating frequency, and ... Reasons for meal termination, eating frequency, and typical meal context differ between persons with and without a spinal cord injury · No full-text available.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07052344?locn=Miami&aggFilters=status:&lastUpdPost=2018-10-19_&viewType=Table&rank=4

Gut-Brain Neural Coupling in Spinal Cord Injury The purpose of this research is to determine the effects of food on brain and stomach activity in persons with and without spinal cord injury (SCI). Official ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12098053/

Nutritional alterations, adverse consequences, and ... Spinal cord injury (SCI) leads to complex nutritional alterations, including energy imbalance, skewed macronutrient and micronutrient intake ...

7. mymedisage.com mymedisage.com/news/early-enteral-feeding-in-spinal-cord-injury-no-clear-evidence-of-harm

Early vs Delayed Enteral Feeding in Spinal Cord Injury The review found no evidence of harm or benefit from early enteral feeding in spinal cord injury patients, with no significant differences ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11948253/

What are the benefits and harms of delayed enteral feeding in ... There is very low-quality evidence that early enteral feeding (initiated less than 72 h into an ICU admission) is as safe as delayed feeding in ...