Preoperative Dietary Fat Consumption and Baseline Inflammatory Markers

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07442981
Status
Completed

Conditions

  • Fat Consumption
  • Inflammatory Markers

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inflammatory markers test in blood prior to surgery — DIAGNOSTIC_TEST
    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
  • Inflammatory markers test in CSF (cerebrospinal fluid) — DIAGNOSTIC_TEST
    1 mL sample will be collected during the standard local anesthesia spinal block or intrathecal morphine injection.
  • MOCA test — DIAGNOSTIC_TEST
    A baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery
  • CAM-3D — DIAGNOSTIC_TEST
    A confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
Feb 2026
Primary completion
Jan 30, 2026
Completion
Jan 30, 2026

Study Design

Enrollment
62 participants (actual)

Arms

  • Arm: Obese BMI + THA/TKA
    Obese with a BMI \>30 undergoing total knee arthroplasty or total hip arthroplasty
  • Arm: Obese BMI + Abdominal/Pelvic
    Obese with a BMI \>30 undergoing abdominal or pelvic surgery
  • Arm: Normal BMI + THA/TKA
    Normal BMI 25-30 undergoing total knee arthroplasty or total hip arthroplasty
  • Arm: Normal BMI + Abdominal/Pelvic
    Normal BMI 25-30 undergoing abdominal or pelvic surgery

Primary Outcome Measure

Correlation between nutritional factors and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery. [ Time Frame: Surgery day and postoperative (PO) Day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wwexner Medical CenterColumbusOhio43210-

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The Ohio State University Wwexner Medical Center· Columbus, OH

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