Gut-Brain Neural Coupling in Spinal Cord Injury

NCT ID: NCT07052344

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-29
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pre-load Condition Meal Group

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

Group Type: EXPERIMENTAL

Preload condition

Intervention Type: 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

Ad-libitum control condition

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Ad-libitum control condition

Intervention Type: 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.

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Gary Farkas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary J Farkas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Guillermo Mederos

Role: CONTACT

gxm1228@med.miami.edu

305-243-4518

Gary J Farkas, PhD

Role: CONTACT

gjf50@med.miami.edu

305-243-4518

Facility Contacts

Gary J Farkas, PhD

Role: primary

gjf50@med.miami.edu

305-243-4518

Guillermo Mederos

Role: backup

gxm1228@med.miami.edu

305-243-3543

Other Identifiers

20250237

Identifier Type: -

Identifier Source: org_study_id