Food Intake and Thermogenesis in High 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 cardiovascular and metabolic health in men with and without spinal cord injury (SCI).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and Women
Physically inactive (<200 minutes per week of moderate-vigorous activity intensity for the preceding 3 months)
Weight stable: body mass ±3 kilograms (kg) for past 3 months
Chronic SCI (≥ 1-year post-injury)
Disqualifiers
Uncompensated thyroid disease
Diabetes
Swallowing or gastrointestinal pathologies
Allergies or aversions to foods/ingredients
Trial design
Design model
Sequential
Treatments tested in this trial
Low meal condition
Other interventionParticipants will consume a standardized meal (500 grams) with a low nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours
Moderate meal condition
Other interventionParticipants will consume a standardized meal (500 grams) with a moderate nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.
High meal condition
Other interventionParticipants will consume a standardized meal (500 grams) with a high nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.
Ad-libitum control condition
Other interventionThe ad-libitum meal consists of 600-700 g of a standardized control meal one time at all visits. Participants will attend one visit per week for 3 weeks. Each visit is separated by one week and each visit will take approximately 6 hours.
Treatment groups
56 Participants
are divided into 3 treatment groupsGroup A: Low meal condition groupExperimental treatment 2 interventions
Group B: Moderate meal condition groupExperimental treatment 2 interventions
Group C: High meal condition groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diet induced thermogenesis (DIT)
Diet-induced thermogenesis (DIT) will be measured using indirect calorimetry. A portable mask-based metabolic system, which will measure expired air to calculate dietary-induced thermogenesis defined as the energy expended above resting and the proportion of meal energy expended postprandially (postprandial kilocalorie (kcal) expended/total meal kcal) where a higher value means more energy is expended.
Time frame
up to 3 weeks (collected during each of the intervention visits)2
Hunger Series Visual Analog Scale
Satiety will be measured using the Hunger Series Visual Analog Scale (HSVAS), which assesses subjective appetite. Each scale is defined at 0 as "not at all hungry" and 100 as "totally/a lot/very hungry". A sum score will be calculated.
Time frame
up to 3 weeks (collected during each of the intervention visits)3
Post ad-libitum energy intake measured in grams
This value will be expressed as a ratio of energy consumed to energy requirements (energy intake/energy requirements x 100) and will be recorded in grams.
Time frame
up to 3 weeks (collected during each of the intervention visits)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
The Craig H. Neilsen Foundation
Collaborator
Source ClinicalTrials.gov