Gut-Brain Neural Coupling in Spinal Cord Injury
ConditionSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
Preload condition
Other interventionParticipants 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
Other interventionParticipants 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Pre-load Condition Meal GroupExperimental treatment 2 interventions
Group B: Ad-libitum Condition Meal GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov