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

February 26, 2026 updated by: Michelle Humeidan, Ohio State University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Surgery day and postoperative (PO) Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At screening (baseline) and three months later after surgery
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.
At hospital discharge (assessed up to 5 days postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Humeidan, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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