NCT07442981

Preoperative Dietary Fat Consumption and Baseline Inflammatory Markers

Pre-op Dietary Fat Intake and Baseline Inflammation in Older Adults Undergoing Major Non-cardiac Surgery: Examining Diet-related Risk Factors for Perioperative Neurocognitive Disorders in Obese and Normal BMI Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: —

Summary

This single-center, prospective pilot study will examine dietary fat consumption and its relationship with inflammatory markers before surgery and the incidence of perioperative neurocognitive disorders in older surgical patients. The study will assess the feasibility getting diet-related information in a surgical setting and will establish baseline dietary patterns in older adults. It will also measure the incidence of postoperative cognitive impairment (POCI) in patients with high fat consumption and gather patient perspectives to inform future nutrition-focused interventions for older surgical candidates.

Detailed description

This single-center, prospective pilot study will evaluate dietary fat intake and its association with preoperative inflammatory markers and perioperative neurocognitive disorders in older surgical patients. The study will assess the feasibility of obtaining detailed dietary information in a surgical population and will establish baseline dietary information in older adults. Participants will complete diet assessments prior to surgery, provide blood samples totaling up to 32 mL (with up to 16 mL collected before surgery and up to 16 mL collected the morning after surgery), and-when available-have up to 1 mL of cerebrospinal fluid collected during their clinically indicated spinal anesthesia procedure. Blood and cerebrospinal fluid samples will be analyzed for inflammatory markers. Cognitive assessments will be performed to evaluate perioperative neurocognitive disorders. Participants will complete a baseline preoperative telephone cognitive assessment to determine cognitive status. Delirium assessments will be conducted twice daily from immediately after surgery until discharge, supplemented by chart review. At three months after surgery, the telephone cognitive assessment will be repeated and compared with the baseline score to estimate persistent neurocognitive disorder.

Conditions

• Fat Consumption
• Inflammatory Markers

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Inflammatory markers test in blood prior to surgery	A total of up to 32 mL of blood, with a maximum of 16 mL collected prior to surgery and another 16 mL will be collected the morning after surgery
DIAGNOSTIC_TEST	Inflammatory markers test in CSF (cerebrospinal fluid)	1 mL sample will be collected during the standard local anesthesia spinal block or intrathecal morphine injection.
DIAGNOSTIC_TEST	MOCA test	A baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery
DIAGNOSTIC_TEST	CAM-3D	A confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States