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Completed

NCT Number: NCT05406739

Feeding Regulation in SCI

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • English speaking

Control Group (Healthy) Participants:

  • Adults (≥ 18 years) without a SCI (will be sex- and age-matched to persons with SCI)
  • English speaking

Exclusion criteria

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
  • 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

Treatment and study plan

Test Meals

Other

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.

Primary outcomes

  1. Gastric emptying time

    Time frame: Up to seven days

    Gastric emptying will be measured by the SmartPill Wireless Motility Capsule

  2. Upper gastrointestinal transit time

    Time frame: Up to seven days

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

Secondary outcomes

  1. Change in postprandial ghrelin

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

    Measured by serum blood samples

  2. Change in postprandial peptide tyrosine tyrosine (PYY)

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

    Measured by serum blood samples

  3. Change in postprandial cholecystokinin (CKK)

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

    Measured by serum blood samples

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

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

    Measured by serum blood samples

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

    Time frame: Baseline and up to 7 days

    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"

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

    Time frame: Baseline and up to 7 days

    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".

  7. Total percentage body fat

    Time frame: Baseline

    Measured by Dual x-ray absorptiometry (DXA)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2022
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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