Inflammation and Protein Restriction

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT03995979
Collaborator
Malcom Randall VA Medical Center (U.S. Fed)
30
2
1
41.3
15
0.4

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
  • Other: 4 Day Protein Restricted Diet
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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity
Actual Study Start Date :
Sep 9, 2019
Anticipated Primary Completion Date :
Feb 16, 2023
Anticipated Study Completion Date :
Feb 16, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT03995979
    Other Study ID Numbers:
    • IRB201900988 -V
    • NF/SGVHS
    First Posted:
    Jun 24, 2019
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 5, 2022