Menu
Recruiting NCT07052344

Gut-Brain Neural Coupling in Spinal Cord Injury

No phase Interventional SCI - Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preload condition, Ad-libitum control condition.
Who it may be relevant to
Registry conditions: SCI - Spinal Cord Injury. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Other Preload condition
    Participants will consume a fixed compulsory preload meal of Campbell's Tomato soup (\~300 grams) 30 minutes after the baseline assessments. Fifteen minutes after consuming the preload meal, participants will receive the ad libitum test meal, consisting of a pre-weighed serving of Stouffer's Macaroni and Cheese (\~700 g).The pre-load condition will be completed at only one of two visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. Duration for the pre-load con
  • Other Ad-libitum control condition
    Participants will only consume the ad libitum test meal, which consists of a pre-weighted serving of Stouffer's Macaroni and Cheese (\~700 g). The ad-libitum meal will be consumed at both visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. The ad-libitum control condition visit will take up to 2 hours.

Primary outcome measures

  • Phase amplitude coupling (PAC) strength [Time frame: up to 2 weeks]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Miami - Miami Project to Cure Paralysis — Miami

Identifiers

NCT: NCT07052344 · 20250237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗