Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pre-load Condition Meal Group
Participants will be in this group for up to 2 weeks.
  • 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 condition visit will be up to 6 hours
  • 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.
Active Comparator
Ad-libitum Condition Meal Group
Participants will be in this group for up to 2 weeks.
  • 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.

Recruiting Locations

University of Miami - Miami Project to Cure Paralysis
Miami, Florida 33136
Contact:
Gary J Farkas, PhD
305-243-4518
gjf50@med.miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.