Inflammation and Protein Restriction

University of Florida

Status: Completed

Conditions: Inflammation; Protein Restriction; Diet

Treatments: Other: 4 Day Protein Restricted Diet

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03995979

IRB201900988 -V

NF/SGVHS (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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, inflammatory bowel disease (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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Protein Restriction Group

Experimental group

Description:

Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.

Treatment:

Other: 4 Day Protein Restricted Diet