Gut-Brain Neural Coupling in Spinal Cord Injury

NCT07052344 | Recruiting

• 1 other identifier: 20250237
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Phase amplitude coupling (PAC) strength

  Gut-brain connectivity will be assessed using phase-amplitude coupling (PAC) to examine the interaction between gastric electrical oscillations and cortical rhythms. PAC will be calculated from electrophysiological raw data to produce one unitless value ranging from -1 to 1, for each subject. The higher the value, the greater the gut-brain connectivity/PAC strength.

  up to 2 weeks

Study Arms (2)

Pre-load Condition Meal Group

EXPERIMENTAL

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

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

Ad-libitum Condition Meal Group

ACTIVE COMPARATOR

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

Other: Ad-libitum control condition

Interventions

Preload condition OTHER

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

Pre-load Condition Meal Group

Ad-libitum control condition OTHER

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.

Ad-libitum Condition Meal Group; Pre-load Condition Meal Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Gary J Farkas, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Mederos

CONTACT

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

Gary J Farkas, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)