Preoperative Dietary Fat Consumption and Baseline Inflammatory Markers (D&D)

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Markers; Fat Consumption
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wwexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

1. ≥ 60 years of age or older
2. Capable and willing to consent
3. English speaking
4. Anticipated ASA physical status I-III
5. Scheduled to undergo major abdominal or pelvic surgery, or total hip or knee joint arthroplasty under general anesthesia with planned spinal anesthetic/analgesic.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
Obese BMI + Abdominal/Pelvic; Obese with a BMI >30 undergoing abdominal or pelvic surgery	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
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; 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
Normal BMI + Abdominal/Pelvic; Normal BMI 25-30 undergoing abdominal or pelvic surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent perioperative neurocognitive disorder will be assessed using the Telephone Montreal Cognitive Assessment (T-MoCA)	Participants will complete a baseline preoperative Telephone Montreal Cognitive Assessment (T-MoCA) to assess cognitive function. Scores on the T-MoCA range from 0 to 30, with higher scores indicating better cognitive performance. The T-MoCA will be re-administered three months after surgery, and scores will be compared with baseline to identify any persistent perioperative neurocognitive disorder.	At screening (baseline) and three months later after surgery
Patient-centered feedback on Nutrition Perceptions, Behaviors, and Pre-Surgical Readiness for Dietary Change Survey	A self-reported questionnaire using ordinal and nominal variables to assess patients' diet perceptions, prior dietary changes, supplement use, and beliefs about the importance and feasibility of nutrition for recovery. Items use Likert-type scales to evaluate attitudes and readiness for behavior change. The survey identifies nutritional attitudes, willingness to modify diet or use supplements, and potential barriers to preoperative nutritional interventions.	At hospital discharge (assessed up to 5 days postoperatively)

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Michelle Humeidan, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024H0245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No