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NCT Number: NCT07442981

Preoperative Dietary Fat Consumption and Baseline Inflammatory Markers

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wwexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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.

Exclusion criteria

  • 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.)

Treatment and study plan

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: At screening (baseline) and three months later after surgery

    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.

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

    Time frame: At hospital discharge (assessed up to 5 days postoperatively)

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: D&D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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