Inflammation and Protein Restriction
Study Details
Study Description
Brief Summary
There is strong scientific data that supports that short-term protein restrictive diets reduce surgical stress responses. The investigators are hoping to use the information collected from the blood serum and muscle tissue of healthy subjects to help understand the baseline and early changes in muscle energetic and cell-mediated inflammation. The study team hopes to use the data collected in this pilot study to compare with patients undergoing open abdominal aortic aneurysm (AAA) repair in a future study
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Modulation of a patient's diet, specifically via short-term dietary protein restriction, can impact changes in cell energetics and dampen the normal subclinical inflammatory state. These changes can provide benchmarks for future research focused on using nutritional interventions aimed at improving the probability of a successful outcome following open aortic aneurysm surgery. The investigators will conduct a short term dietary restriction protocol to characterize these changes in a normal control cohort to be compared to patients which undergo surgery, to identify the optimal time points for sampling in the surgical population. These changes will be characterized by looking at inflammatory cells in the blood, proteins excreted in the urine, changes in microbiome signature identified by stool sample and oral swab, as well as changes in muscle energetics in small muscle biopsies.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Protein Restriction Group Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. |
Other: 4 Day Protein Restricted Diet
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. They may also drink water. No food, other beverages, or alcohol may be consumed. The amount of diet to be consumed will be calculated for each patient based upon resting energy expenditures plus additional energy needs. These will be consumed by the study subjects at home in an unrestricted manner, in that they may be consumed at any point of time in the day.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in inflammatory cell composition [Day 2; Day 4; Day 7; Day 14]
A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
- Healthy volunteers between 18 and 70 years of age
Exclusion Criteria:
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Age less than 18 years.
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The presence of any significant medical condition that might significantly confound the collection of biological data in the study including cancer, diabetes, IBD, Advanced Renal Disease, Nut Allergy
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Unwilling to follow protocol
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Participation in another interventional clinical trial.
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Prisoners, pregnancy, or direct employees of the investigative team
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Malcom Randall VA Medical Center | Gainesville | Florida | United States | 32608 |
2 | UF Health---Vascular Surgery | Gainesville | Florida | United States | 32611 |
Sponsors and Collaborators
- University of Florida
- Malcom Randall VA Medical Center
Investigators
- Principal Investigator: Salvatore Scali, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB201900988 -V
- NF/SGVHS