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Spinal Cord InjuriesNCT05406739

Feeding Regulation in SCI

A study testing Test Meals in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall purpose of this research is to understand the reasons why persons with spinal cord injuries eat more calories than they need to "burn", stay alive, and function. This research will investigate how quickly food moves through a participant's body, the hormones in the participant's body that control energy… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Test Meals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
5 Jan 2023to 24 Jan 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Spinal Cord Injury (SCI) Participants:
  • Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI
  • Chronic SCI, denoted as ≥ 12 months post-injury
  • American Spinal Injury Association Impairment Scale164 A, B, and C
  • Persons with tetraplegia self-report they are able to feed themselves
  • Self-report on a bowel care program every-other-day
Show all 10Show fewer
  • English speaking
  • Control Group (Healthy) Participants:
  • Adults (≥ 18 years) without a SCI (will be sex- and age-matched to persons with SCI)
  • English speaking

Who cannot join

  • For All Participants:
  • Currently on a weight loss program/diet and/or actively trying to lose weight
  • Have a self-reported history of
  • Diabetes
  • Thyroid disease
  • Gastrointestinal disease
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  • Previous abdominal surgery ≤ 3 months prior to the study
  • Peripheral nervous system prosthesis
  • Swallowing disorders
  • Self-reported food allergies to or dislike the test meals.
  • Self-reported use of a prokinetic agent, antipsychotic agent, or Glucagon like Peptide 1 (GLP-1) agonists
  • Individuals who are not yet adults (infants, children, teenagers)
  • Women that self-report they are pregnant or likely to become pregnant
  • Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury

The overall purpose of this research is to understand the reasons why persons with spinal cord injuries eat more calories than they need to "burn", stay alive, and function. This research will investigate how quickly food moves through a participant's body, the hormones in the participant's body that control energy and digestion, and a participant's impressions of hunger after eating a meal. This will be compared in persons with and without a spinal cord injury.

Being tested
Test Meals
Keywords
gut, eating, appetite, hormone
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test MealsOther

    For the first meal, Participants will be fasted for 8 hours and will consume a test meal of 255 calories (120 g egg substitute [60 kcal]; 2 slices of bread [120 kcal] with 30 g strawberry jam [75 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 120 mL of water.

    After five to seven days, participants will be fasted for 10 hours and will consume a second test meal of 510 calories (240 g egg substitute [120 kcal]; 4 slices of bread [240 kcal] with 60 g strawberry jam [150 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 240 mL of water.

Study groups in NCT05406739
Study groupRoleWhat they receive
Spinal Cord Injury GroupExperimentalParticipants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.
Receives: Other: Test Meals
Control GroupActive comparatorParticipants without a spinal cord injury will receive two meals on two separate visits between five to seven days.
Receives: Other: Test Meals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric emptying time

    Gastric emptying will be measured by the SmartPill Wireless Motility Capsule

    Measured: Up to seven days

  2. Upper gastrointestinal transit time

    Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule

    Measured: Up to seven days

Secondary outcomes (7)

  1. Change in postprandial ghrelin

    Measured by serum blood samples

    Measured: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

  2. Change in postprandial peptide tyrosine tyrosine (PYY)

    Measured by serum blood samples

    Measured: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

  3. Change in postprandial cholecystokinin (CKK)

    Measured by serum blood samples

    Measured: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

  4. Change in postprandial Glucagon Peptide 1 (GLP-1)

    Measured by serum blood samples

    Measured: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

  5. Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale

    Change in subjective appetite rating will be measured by Palatability Series Visual Analogue Scale that ranges from 0 mm as "not pleasant" to 100 mm as "extremely pleasant"

    Measured: Baseline and up to 7 days

  6. Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale

    Change in subjective appetite rating will be measured by Hunger Series Visual Analogue Scale that ranges from 0 mm as "not at all hungry" to 100 mm as "totally/a lot/very hungry".

    Measured: Baseline and up to 7 days

  7. Total percentage body fat

    Measured by Dual x-ray absorptiometry (DXA)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2022
  2. Study start5 Jan 2023
  3. Primary completion24 Jan 2024
  4. Study completion24 Jan 2024

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05406739
Sponsor's protocol ID
20220407
Status last verified
Feb 2024
First submitted
1 Jun 2022
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Farkas GJ, Sneij A, McMillan DW, Tiozzo E, Nash MS, Gater DR Jr. Energy expenditure and nutrient intake after spinal cord injury: a comprehensive review and practical recommendations. Br J Nutr. 2022 Sep 14;128(5):863-887. doi: 10.1017/S0007114521003822. Epub 2021 Sep 23.

    PubMed 34551839

  • Farkas GJ, Sneij A, Gater DR Jr. Dietetics After Spinal Cord Injury: Current Evidence and Future Perspectives. Top Spinal Cord Inj Rehabil. 2021;27(1):100-108. doi: 10.46292/sci20-00031.

    PubMed 33814888

  • Farkas GJ, Sneij A, Gater DR Jr. Energy Expenditure Following Spinal Cord Injury: A Delicate Balance. Top Spinal Cord Inj Rehabil. 2021;27(1):92-99. doi: 10.46292/sci20-00030.

    PubMed 33814887

  • Farkas GJ, Gater DR. Energy Expenditure and Nutrition in Neurogenic Obesity following Spinal Cord Injury. J Phys Med Rehabil. 2020;2(1):11-13. No abstract available.

    PubMed 32226945

  • Farkas GJ, Pitot MA, Gater Jr. DR. A Systematic Review of the Accuracy of Estimated and Measured Resting Metabolic Rate in Chronic Spinal Cord Injury. Int J Sport Nutr Exerc Metab. 2019 Sep 1;29(5):548-558. doi: 10.1123/ijsnem.2018-0242.

    PubMed 31034249

  • Farkas GJ, Gorgey AS, Dolbow DR, Berg AS, Gater DR. Caloric Intake Relative to Total Daily Energy Expenditure Using a Spinal Cord Injury-Specific Correction Factor: An Analysis by Level of Injury. Am J Phys Med Rehabil. 2019 Nov;98(11):947-952. doi: 10.1097/PHM.0000000000001166.

    PubMed 30817378

  • Farkas GJ, Pitot MA, Berg AS, Gater DR. Nutritional status in chronic spinal cord injury: a systematic review and meta-analysis. Spinal Cord. 2019 Jan;57(1):3-17. doi: 10.1038/s41393-018-0218-4. Epub 2018 Nov 12.

    PubMed 30420688

Questions about this trial

What is this clinical trial studying?

A study testing Test Meals 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 10 inclusion and 14 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 14 Feb 2024. 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?

Gastric emptying time (time frame: Up to seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05406739, which also lists 7 linked publications.

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 14 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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