Gut-Brain Neural Coupling in Spinal Cord Injury

University of Miami

Status: Enrolling

Conditions: SCI - Spinal Cord Injury

Treatments: Other: Preload condition; Other: Ad-libitum control condition

Study type: Interventional

Funder types: Other

Identifiers

NCT07052344

20250237

Details and patient eligibility

About

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).

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria, SCI and Controls

• Adults, 18 to 70 years of age.
• Sex, male or female.
• 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, SCI and Controls

• 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.
• Vagus or recurrent laryngeal nerve injury (self-report).
• Uncontrolled thyroid disease, such that they are not on thyroid medication (e.g., levothyroxine) to treat the condition (self-report)
• Diabetes (type 1 or type 2) and/or currently taking anti-diabetic or glucagon-like peptide-1 (GLP-1)/dual agonist medications (self-report).
• Gastrointestinal disease (self-report), such as inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, irritable bowel syndrome, gastroesophageal reflux disease, peptic ulcer disease, chronic pancreatitis, liver cirrhosis, and any condition requiring gastrointestinal surgery (e.g., bowel resection, colostomy, or ileostomy).
• Swallowing disorder (self-report).
• History of bariatric surgery
• Food allergies/dislikes or dietary restrictions (i.e. vegan) (self-report).
• Allergy to adhesives (self-report)
• Open abdominal wounds or abdominal skin not intact.
• Current use of probiotics/prebiotics (self-report).
• Current use of medications that can impact appetite, body weight, and/or bowel function, such as prokinetic, antiemetic, narcotic analgesics, anticholinergic, anti-inflammatory, antipsychotic, or anti-obesity agents (self-report).
• Pregnant (determined by urine pregnancy test) or breastfeeding women.
• Non-adults (infants, children, teenagers).
• Adults unable to consent
• Prisoner.

SCI-specific Eligibility Criteria

Inclusion Criteria, SCI Only

• At least 12 months post-SCI, denoting chronic injury
• Complete American Spinal Injury Association (ASIA) Impairment Scale (AIS A) or motor-incomplete (AIS B) tetraplegia (SCI at or above C8 lesion)
• Able to self-feed (self-report)
• On a bowel care program every day or every other day (self-report).

Exclusion Criteria, SCI Only

• Under 12 months post-SCI.
• Motor-incomplete (AIS C, D) paraplegia (SCI below C8 lesion), including thoracic, lumbar, and sacral injuries.
• Ventilator-dependence (self-report).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Pre-load Condition Meal Group

Experimental group

Description:

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

Treatment:

Other: Ad-libitum control condition

Other: Preload condition

Ad-libitum Condition Meal Group

Active Comparator group

Description:

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

Treatment:

Other: Ad-libitum control condition