Postprandial Lipid Tracer and Exercise in Spinal Cord Injury

NCT03691532 | Completed

• 1 other identifier: 20180450
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of upper extremity exercise on postprandial lipemia (PPL) in persons with spinal cord injury (SCI). Participants are measured at rest and fed a standardized meal following seated rest (CON) or arm cycling exercise (ACE). The meal is infused with "stable isotope lipid tracers" that allow for determination of the end fates of the fat in the meal.

Conditions

Spinal Cord Injuries

Keywords

lipemia; feeding; paraplegia; tetraplegia; physical activity; macronutrient metabolism

Outcome Measures

Primary Outcomes (1)

• Rates of postprandial exogenous vs. endogenous fat use

  Indirect calorimetry data (rates of CO2 production and O2 consumption) will be input into stoichiometric equations to calculate the rate of whole body fat oxidation (grams/minute). Breath carbon-13 carbon dioxide (13CO2) enrichment data combined with the rate CO2 production from indirect calorimetry will allow for the determination of the individual rates of exogenous and endogenous fat use.

  400 minutes

Secondary Outcomes (5)

• Contribution of exogenous fat to postprandial changes in plasma triglycerides

  400 minutes

• Concentration of fats in the blood

  460 minutes

• Concentration of sugar in the blood

  460 minutes

• Concentration of hormones in the blood

  460 minutes

• Markers of systemic inflammation

  Baseline

Study Arms (2)

Seated control (CON)

EXPERIMENTAL

Participants remain seated in their habitual wheel chair for \~60 min (duration of exercise performed in other arm). Following the intervention they are fed a liquid meal.

Behavioral: Seated control (CON); Behavioral: Liquid meal

Arm cycle exercise (ACE)

EXPERIMENTAL

Participants complete continuous arm cycle exercise (ACE) for \~60 min. Following the intervention they are fed a liquid meal.

Behavioral: Arm cycle exercise (ACE); Behavioral: Liquid meal

Interventions

Seated control (CON) BEHAVIORAL

Seated rest

Seated control (CON)

Arm cycle exercise (ACE) BEHAVIORAL

Arm cycling at a continuous power output

Arm cycle exercise (ACE)

Liquid meal BEHAVIORAL

Liquid meal of 0.5 L volume containing 20 kcal/kg fat free mass (FFM) and 5 mg/kg FFM of uniformly 13-carbon labeled palmitate (\[U-13C\]palmitate) at a macronutrient distribution of 50% carbohydrate, 35% fat, and 15% protein (by kcal).

Arm cycle exercise (ACE); Seated control (CON)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males aged 18-60 years.
• For the spinal cord injury subgroups, the participant's injury will be:
• neurologically stable,
• American Spinal Injury Association (ASIA) Impairment Scale A-C,
• and will have occurred \> 1 year from the testing date.

You may not qualify if:

• Existing diagnosis of cardiovascular disease or diabetes.
• Contraindication to exercise (ACSM Guideline, 10th edition).
• Lower extremity fracture or dislocation within 6 months of participation.
• History of head injury or seizures.
• Inability to consent.
• Restrictions in upper extremity range of motion that would prevent an individual from achieving an unhindered arm cycling motion or moving throughout a range needed to perform resistance maneuvers.
• A pressure ulcer at ischial/gluteus, trochanteric, sacral, or heel sites within the last 3 months.
• Imprisonment in state or federal jail or prison.

Sponsors & Collaborators

• University of Miami: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Lois Pope Life Center

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Hyperlipidemias; Paraplegia; Quadriplegia; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kevin A Jacobs, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Mixed-crossover: three separate groups (paraplegia, tetraplegia, and neurologically intact) undergo two conditions (seated control and exercise) in a randomized order.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: October 1, 2018
• Study Start: May 30, 2018
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)