Fat ConsumptionD&DNCT07442981
Preoperative Dietary Fat Consumption and Baseline Inflammatory Markers
An observational study of Fat Consumption and Inflammatory Markers, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fat Consumption, Inflammatory Markers
- What is being tested?
- Inflammatory markers test in blood prior to surgery, Inflammatory markers test in CSF (cerebrospinal fluid) and MOCA test
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wwexner Medical Center
Columbus, Ohio, 43210
About this study
Official 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
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.
Read the 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.
- Conditions
- Fat Consumption, Inflammatory Markers
- Being tested
- Inflammatory markers test in blood prior to surgery, Inflammatory markers test in CSF (cerebrospinal fluid), MOCA test, CAM-3D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory markers test in blood prior to surgeryDiagnostic 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 testDiagnostic test
A baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery
CAM-3DDiagnostic test
A confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge
| Study group | Role | What they receive |
|---|---|---|
| Obese BMI + THA/TKA | Obese with a BMI >30 undergoing total knee arthroplasty or total hip arthroplasty Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: At hospital discharge (assessed up to 5 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start25 Mar 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat ConsumptionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Humeidan, Ohio State University
- Investigators
- Michelle Humeidan, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442981
- Sponsor's protocol ID
- 2024H0245
- Acronym
- D&D
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07442981
- Acronym / sponsor ID
- D&D / 2024H0245
- Conditions
- Fat Consumption, Inflammatory Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese BMI + THA/TKA | – | 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-3DObese with a BMI >30 undergoing total knee arthroplasty or total hip arthroplasty |
| Obese BMI + Abdominal/Pelvic | – | 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-3DObese with a BMI >30 undergoing abdominal or pelvic surgery |
| Normal BMI + THA/TKA | – | 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-3DNormal BMI 25-30 undergoing total knee arthroplasty or total hip arthroplasty |
| Normal BMI + Abdominal/Pelvic | – | 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-3DNormal BMI 25-30 undergoing abdominal or pelvic surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory markers test in blood prior to surgeryA 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 | Normal BMI + Abdominal/Pelvic, Normal BMI + THA/TKA, Obese BMI + Abdominal/Pelvic, Obese BMI + THA/TKA |
| 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 | Normal BMI + Abdominal/Pelvic, Normal BMI + THA/TKA, Obese BMI + Abdominal/Pelvic, Obese BMI + THA/TKA |
| MOCA testA baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery | Diagnostic test | Normal BMI + Abdominal/Pelvic, Normal BMI + THA/TKA, Obese BMI + Abdominal/Pelvic, Obese BMI + THA/TKA |
| CAM-3DA confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge | Diagnostic test | Normal BMI + Abdominal/Pelvic, Normal BMI + THA/TKA, Obese BMI + Abdominal/Pelvic, Obese BMI + THA/TKA |
Primary outcome
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.
2 secondary outcomes
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Humeidan principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fat Consumption and Inflammatory Markers, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.