Spinal Cord InjuriesPPLTNCT03691532
Postprandial Lipid Tracer and Exercise in Spinal Cord Injury
A study testing Arm cycle exercise (ACE) and Liquid meal in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Arm cycle exercise (ACE) and Liquid meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries
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.
Read the detailed description
Spinal cord injury (SCI) results in dysregulation of fat metabolism that increases the risk of morbidity and mortality from cardioendocrine disease. Excessive accumulation of visceral fat after SCI is a serious risk component for cardioendocrine disease and results in part from pronounced hypertriglyceridemia following ingestion of fat-containing meals (i.e., exaggerated postprandial lipemia; PPL). Although exaggerated PPL is well documented in persons with SCI, its etiology is unknown. Specifically, it remains to be determined to what extent exaggerated PPL in those with SCI results from impairments in the use of exogenous (dietary) and/or endogenous (stored) fats. Additionally, it is not known if exercise improves postprandial fat use in a manner that alleviates the exaggerated PPL in this population and reduces the risk of cardioendocrine disease.
The objective of the this study is to examine the mechanisms of exaggerated PPL in those with SCI and the effects of an acute pre-meal exercise bout by employing novel stable isotope tracer techniques. In persons without SCI, it is well established that pre-meal exercise lowers PPL in part by improving the use of exogenous and endogenous fats. While muscle atrophy and blunted sublesional sympathetic activity following SCI may hinder fat use, preliminary data indicate that fat use is increased during recovery from exercise in the postabsorptive (fasted) state in this population. Thus, the investigators hypothesize that decreased use of exogenous and endogenous fats contributes to exaggerated PPL in SCI, and that pre-meal exercise will reduce PPL due to increased use of both fat sources.
- Conditions
- Spinal Cord Injuries
- Being tested
- Seated control (CON), Arm cycle exercise (ACE), Liquid meal
- Keywords
- lipemia, feeding, paraplegia, tetraplegia, physical activity, macronutrient metabolism
- Medical subject headings
- Spinal Cord Injuries, Hyperlipidemias, Paraplegia, Quadriplegia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated control (CON)Behavioural
Seated rest
Arm cycle exercise (ACE)Behavioural
Arm cycling at a continuous power output
Liquid mealBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Arm cycle exercise (ACE); Behavioral: Liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 400 minutes
Secondary outcomes (5)
Contribution of exogenous fat to postprandial changes in plasma triglycerides
Carbon-13 palmitate ([U-13C] enrichment data will allow for the determination of the contribution of exogenous fat to the total blood triglyceride concentration. The contribution of endogenous fat to the total blood triglyceride concentration will be calculated by subtracting the exogenous fat contribution from the total blood triglyceride concentration.
Measured: 400 minutes
Concentration of fats in the blood
Concentration of triglycerides, non-esterified fatty acids, and glycerol in the blood before and after a test meal.
Measured: 460 minutes
Concentration of sugar in the blood
Concentration of glucose in the blood before and after a test meal.
Measured: 460 minutes
Concentration of hormones in the blood
Concentration of insulin and catecholamines in the blood before and after a test meal.
Measured: 460 minutes
Markers of systemic inflammation
Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start30 May 2018
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Mixed-crossover: three separate groups (paraplegia, tetraplegia, and neurologically intact) undergo two conditions (seated control and exercise) in a randomized order.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Kevin Allen Jacobs, University of Miami
- Investigators
- Kevin A Jacobs, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691532
- Sponsor's protocol ID
- 20180450
- Acronym
- PPLT
- Status last verified
- Aug 2023
- First submitted
- 25 Jun 2018
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT03691532
- Acronym / sponsor ID
- PPLT / 20180450
- Conditions
- Spinal Cord Injuries
- Keywords
- lipemia, feeding, paraplegia, tetraplegia, physical activity, macronutrient metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal cord injury (SCI) results in dysregulation of fat metabolism that increases the risk of morbidity and mortality from cardioendocrine disease. Excessive accumulation of visceral fat after SCI is a serious risk component for cardioendocrine disease and results in part from pronounced hypertriglyceridemia following ingestion of fat-containing meals (i.e., exaggerated postprandial lipemia; PPL). Although exaggerated PPL is well documented in persons with SCI, its etiology is unknown. Specifically, it remains to be determined to what extent exaggerated PPL in those with SCI results from impairments in the use of exogenous (dietary) and/or endogenous (stored) fats. Additionally, it is not known if exercise improves postprandial fat use in a manner that alleviates the exaggerated PPL in this population and reduces the risk of cardioendocrine disease.
The objective of the this study is to examine the mechanisms of exaggerated PPL in those with SCI and the effects of an acute pre-meal exercise bout by employing novel stable isotope tracer techniques. In persons without SCI, it is well established that pre-meal exercise lowers PPL in part by improving the use of exogenous and endogenous fats. While muscle atrophy and blunted sublesional sympathetic activity following SCI may hinder fat use, preliminary data indicate that fat use is increased during recovery from exercise in the postabsorptive (fasted) state in this population. Thus, the investigators hypothesize that decreased use of exogenous and endogenous fats contributes to exaggerated PPL in SCI, and that pre-meal exercise will reduce PPL due to increased use of both fat sources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed-crossover: three separate groups (paraplegia, tetraplegia, and neurologically intact) undergo two conditions (seated control and exercise) in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Seated control (CON) | Experimental | Behavioral: Seated control (CON), Behavioral: Liquid mealParticipants 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. |
| Arm cycle exercise (ACE) | Experimental | Behavioral: Arm cycle exercise (ACE), Behavioral: Liquid mealParticipants complete continuous arm cycle exercise (ACE) for ~60 min. Following the intervention they are fed a liquid meal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males aged 18-60 years.
- For the spinal cord injury subgroups, the participant's injury will be:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seated control (CON)Seated rest | Behavioural | Seated control (CON) |
| Arm cycle exercise (ACE)Arm cycling at a continuous power output | Behavioural | Arm cycle exercise (ACE) |
| Liquid mealLiquid 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). | Behavioural | Arm cycle exercise (ACE), Seated control (CON) |
Primary outcome
Rates of postprandial exogenous vs. endogenous fat use
Time frame: 400 minutes
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.
5 secondary outcomes
Contribution of exogenous fat to postprandial changes in plasma triglycerides
Time frame: 400 minutes
Concentration of fats in the blood
Time frame: 460 minutes
Concentration of sugar in the blood
Time frame: 460 minutes
Concentration of hormones in the blood
Time frame: 460 minutes
Markers of systemic inflammation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin A Jacobs, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm cycle exercise (ACE) and Liquid meal in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of postprandial exogenous vs. endogenous fat use (time frame: 400 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.