Preoperative Dietary Fat Consumption and Baseline Inflammatory Markers

NCT07442981 | Completed

• 1 other identifier: 2024H0245
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fat Consumption; Inflammatory Markers

Outcome Measures

Primary Outcomes (1)

• Correlation between nutritional factors and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery.

  Correlation between pre-surgery nutritional factors (fat intake, BMI, waist circumference, frailty status) and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery.

  Surgery day and postoperative (PO) Day 1

Secondary Outcomes (2)

• Persistent perioperative neurocognitive disorder will be assessed using the Telephone Montreal Cognitive Assessment (T-MoCA)

  At screening (baseline) and three months later after surgery

• Patient-centered feedback on Nutrition Perceptions, Behaviors, and Pre-Surgical Readiness for Dietary Change Survey

  At hospital discharge (assessed up to 5 days postoperatively)

Study Arms (4)

Obese BMI + THA/TKA

Obese with a BMI \>30 undergoing total knee arthroplasty or total hip arthroplasty

Diagnostic Test: Inflammatory markers test in blood prior to surgery; Diagnostic Test: Inflammatory markers test in CSF (cerebrospinal fluid); Diagnostic Test: MOCA test; Diagnostic Test: CAM-3D

Obese BMI + Abdominal/Pelvic

Obese with a BMI \>30 undergoing abdominal or pelvic surgery

Diagnostic Test: Inflammatory markers test in blood prior to surgery; Diagnostic Test: Inflammatory markers test in CSF (cerebrospinal fluid); Diagnostic Test: MOCA test; Diagnostic Test: CAM-3D

Normal BMI + THA/TKA

Normal BMI 25-30 undergoing total knee arthroplasty or total hip arthroplasty

Diagnostic Test: Inflammatory markers test in blood prior to surgery; Diagnostic Test: Inflammatory markers test in CSF (cerebrospinal fluid); Diagnostic Test: MOCA test; Diagnostic Test: CAM-3D

Normal BMI + Abdominal/Pelvic

Normal BMI 25-30 undergoing abdominal or pelvic surgery

Diagnostic Test: Inflammatory markers test in blood prior to surgery; Diagnostic Test: Inflammatory markers test in CSF (cerebrospinal fluid); Diagnostic Test: MOCA test; Diagnostic Test: CAM-3D

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

Normal BMI + Abdominal/Pelvic; Normal BMI + THA/TKA; Obese BMI + Abdominal/Pelvic; Obese BMI + THA/TKA

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.

Normal BMI + Abdominal/Pelvic; Normal BMI + THA/TKA; Obese BMI + Abdominal/Pelvic; Obese BMI + THA/TKA

MOCA test DIAGNOSTIC_TEST

A baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery

Normal BMI + Abdominal/Pelvic; Normal BMI + THA/TKA; Obese BMI + Abdominal/Pelvic; Obese BMI + THA/TKA

CAM-3D DIAGNOSTIC_TEST

A confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge

Normal BMI + Abdominal/Pelvic; Normal BMI + THA/TKA; Obese BMI + Abdominal/Pelvic; Obese BMI + THA/TKA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese or normal weight patients over the age of 60 scheduled to undergo a major abdominal or pelvic surgery, or total hip or knee joint arthroplasty at OSUWMC and complete the study.

You may qualify if:

• ≥ 60 years of age or older
• Capable and willing to consent
• English speaking
• Anticipated ASA physical status I-III
• Scheduled to undergo major abdominal or pelvic surgery, or total hip or knee joint arthroplasty under general anesthesia with planned spinal anesthetic/analgesic.

You may not qualify if:

• Illiterate
• ASA physical status V, VI
• Active Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol, or drug abuse.
• Preoperative benzodiazepine administration (i.e. Midazolam, Diazepam)
• Past medical history of any inflammatory autoimmune disease processes (rheumatic arthritis (RA), systemic lupus erythematosus (SLE), autoinflamatory syndrome, etc.)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wwexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Michelle Humeidan

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: March 2, 2026
• Study Start: March 25, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)