NCT05406739

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

June 1, 2022

Last Update Submit

February 13, 2024

Conditions

Spinal Cord Injuries

Keywords

guteatingappetitehormone

Outcome Measures

Primary Outcomes (2)

  • Gastric emptying time

    Gastric emptying will be measured by the SmartPill Wireless Motility Capsule

    Up to seven days

  • Upper gastrointestinal transit time

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

    Up to seven days

Secondary Outcomes (7)

  • Change in postprandial ghrelin

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

  • Change in postprandial peptide tyrosine tyrosine (PYY)

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

  • Change in postprandial cholecystokinin (CKK)

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

  • Change in postprandial Glucagon Peptide 1 (GLP-1)

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

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

    Baseline and up to 7 days

  • +2 more secondary outcomes

Study Arms (2)

Spinal Cord Injury Group

EXPERIMENTAL

Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.

Other: Test Meals

Control Group

ACTIVE COMPARATOR

Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.

Other: Test Meals

Interventions

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.

Control GroupSpinal Cord Injury Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (7)

  • 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.

    PMID: 34551839BACKGROUND

  • 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.

    PMID: 33814888BACKGROUND

  • 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.

    PMID: 33814887BACKGROUND

  • 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.

    PMID: 32226945BACKGROUND

  • 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.

    PMID: 31034249BACKGROUND

  • 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.

    PMID: 30817378BACKGROUND

  • 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.

    PMID: 30420688RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Gary J Farkas, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Associate

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

January 5, 2023

Primary Completion

January 24, 2024

Study Completion

January 24, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)