Inflammation and Protein Restriction

  • STATUS
    Recruiting
  • days left to enroll
    11
  • participants needed
    30
  • sponsor
    University of Florida
Updated on 4 October 2022
Accepts healthy volunteers

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

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.

Details
Condition Protein Restriction, Diet, Inflammation
Treatment 4 Day Protein Restricted Diet
Clinical Study IdentifierNCT03995979
SponsorUniversity of Florida
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy volunteers between 18 and 70 years of age

Exclusion Criteria

Age less than 18 years
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
Unwilling to follow protocol
Participation in another interventional clinical trial
Prisoners, pregnancy, or direct employees of the investigative team
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