Recruiting

Carbohydrate Loading

Sponsor:

Horizon Health Network

Code:

NCT05778487

Conditions

Diet, Carbohydrate Loading

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Gatorade Thirst Quencher

Study Details

Brief summary:

Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Elderly patients (65 years of age and older) represent a large number of spine surgery recipients and due to the unique aspects of aging, proper preoperative nutrition is essential for this patient demographic. The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay (LOS) in hospital and reducing perioperative patient adverse events, when undergoing orthopaedic spine surgeries. It is expected that preoperative carbohydrate loading in elderly patients receiving an orthopaedic spine surgery (fusion, decompression, or discectomy) will lead to greater outcomes through decreasing LOS in hospital and reducing perioperative patient adverse events compared to patients who did not receive preoperative carbohydrate loading.

Conditions

Diet, Carbohydrate Loading

Study ID

NCT05778487

Start date

Jul 13, 2022

Status verified date

Mar, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must meet the age requirement,
  • Have either recently undergone, or are scheduled to undergo an elective cervical or thoracolumbar spine surgery, including fusion, decompression, and discectomy procedures.

Exclusion Criteria:

  • Potential participants will be excluded if they do not meet the age requirements,
  • Have had, or will be having, cervical or thoracolumbar fusion, decompression or discectomy revision surgery,
  • Are not able to consume the selected carbohydrate drink,
  • Do not consent to participation in the research study,
  • Or have diabetes.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control Group

Standard of care for dietary instructions only.

The control group will consist of retrospectively recruited participants who have recently undergone a successful elective spine surgery, and followed the preoperative nutrition standards for their surgery, as outlined by the research institution's fasting dietary guidelines. Recruitment will include the most recent spine surgeries that meet the inclusion criteria and match prospective patient demographics.

experimental: Carbohydrate Group

Standard of care for dietary instructions + carbohydrate loading.

The carbohydrate (CHO) group will consist of prospectively recruited patients scheduled to undergo an elective spine surgery. These participants will also follow the preoperative nutrition standards, however, in addition, they will be instructed to consume 710ml of a simple, commercial carbohydrate sports drink on the day of their procedure up to 2 hours prior to surgery.

Interventions

Gatorade Thirst Quencher

Gatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml)

Primary outcome measure

  • Length of Stay (LOS) in Hospital [ Time Frame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required. ]

Central Contacts and Locations

Central contacts

Canada East Spine Centre

506-566-1451cescresearch@gmail.com

Kevan Kostynski

kevan.kostynski@dal.ca

Locations

Canada East Spine Centre at Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Contacts

Canada East Spine Centre

506-566-1451cescresearch@gmail.com

Kevan Kostynski

kevan.kostynski@dal.ca

Principal Investigator:

Chris Small, MD

More Information

Sponsor

Horizon Health Network

Last update posted

Mar 21, 2023

Last verified

Mar, 2023

Keywords

  • Carbohydrate Loading
  • Orthopaedics
  • Elderly
  • Spine
  • Cervical
  • Thoracolumbar
  • Fusion
  • Decompression
  • Discectomy
  • Gatorade

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Horizon Health Network on 2023-03-21.