Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT07052344

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Preload condition

Ad-libitum control condition

Study Details

Brief summary:

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).

Conditions

SCI - Spinal Cord Injury

Study ID

NCT07052344

Start date

Oct 29, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pre-load Condition Meal Group

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

active comparator: Ad-libitum Condition Meal Group

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

Interventions

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 condition visit will be up to 6 hours

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 measure

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

Central Contacts and Locations

Central contacts

Guillermo Mederos

305-243-4518gxm1228@med.miami.edu

Gary J Farkas, PhD

305-243-4518gjf50@med.miami.edu

Locations

University of Miami - Miami Project to Cure Paralysis

Recruiting

Miami, Florida, United States, 33136

Contacts

Gary J Farkas, PhD

305-243-4518gjf50@med.miami.edu

Guillermo Mederos

305-243-3543gxm1228@med.miami.edu

Principal Investigator:

Gary J Farkas, PhD

More Information

Sponsor

University of Miami

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.