SCI - Spinal Cord Injury
Conditions
Brief summary
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).
Interventions
OTHERLow meal condition
Participants 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
OTHERModerate meal condition
Participants 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.
OTHERHigh meal condition
Participants 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.
The 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.
Sponsors
University of Miami
The Craig H. Neilsen Foundation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
SCI and Controls * Men * Physically inactive (\<150 minutes per week of moderate-vigorous activity intensity for the preceding 3 months) * Weight stable: body mass ±3 kilograms (kg) for past 3 months SCI Only * Chronic SCI (≥ 1-year post-injury) * Motor-complete SCI American Spinal Injury Association Impairment Scale (AIS) A and B * T6 injuries and above that can independently feed themselves
Exclusion criteria
SCI and Controls * Uncompensated thyroid disease * Diabetes * Swallowing or gastrointestinal pathologies * Allergies or aversions to foods/ingredients * Prescribed prokinetic, antipsychotic, or anti-obesity agents SCI Only * Incomplete SCI AIS C or D * Ventilator-dependent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet induced thermogenesis (DIT) | up to 3 weeks (collected during each of the intervention visits) | 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. |
| Hunger Series Visual Analog Scale | up to 3 weeks (collected during each of the intervention visits) | 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. |
| Post ad-libitum energy intake measured in grams | up to 3 weeks (collected during each of the intervention visits) | 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. |
Countries
United States
Contacts
CONTACTGuillermo Mederos
CONTACTGary J Farkas, PhD
PRINCIPAL_INVESTIGATORGary J Farkas, PhD
University of Miami
Outcome results
None listed