Inflammation and Protein Restriction

Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Diet; Protein Restriction
• Intervention / Treatment: Other: 4 Day Protein Restricted Diet

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Scali, MD; Phone Number: 352-273-5484; Email: salvatore.scali@surgery.ufl.edu
• Study Contact Backup: Name: Christine Ferguson; Phone Number: 352.548.6217; Email: Christine.Ferguson@surgery.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Center
    • Gainesville, Florida, United States, 32611
      • UF Health---Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: Scandishake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory cell composition	A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis	Day 2; Day 4; Day 7; Day 14

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Malcom Randall VA Medical Center
• Investigators: Principal Investigator: Salvatore Scali, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: IRB201900988 -V; NF/SGVHS (Other Identifier: Malcom Randall VA Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No