Inflammation and Protein Restriction
Primary Purpose
Protein Restriction, Diet, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4 Day Protein Restricted Diet
Sponsored by
About this trial
This is an interventional basic science trial for Protein Restriction
Eligibility Criteria
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
Sites / Locations
- Malcom Randall VA Medical CenterRecruiting
- UF Health---Vascular SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Protein Restriction Group
Arm Description
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.
Outcomes
Primary Outcome Measures
Change in inflammatory cell composition
A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT03995979
First Posted
June 21, 2019
Last Updated
May 8, 2023
Sponsor
University of Florida
Collaborators
Malcom Randall VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03995979
Brief Title
Inflammation and Protein Restriction
Official Title
Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
February 16, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Malcom Randall VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Restriction, Diet, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protein Restriction Group
Arm Type
Experimental
Arm Description
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.
Intervention Type
Other
Intervention Name(s)
4 Day Protein Restricted Diet
Other Intervention Name(s)
Scandishake
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in inflammatory cell composition
Description
A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis
Time Frame
Day 2; Day 4; Day 7; Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvatore Scali, MD
Phone
352-273-5484
Email
salvatore.scali@surgery.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Ferguson
Phone
352.548.6217
Email
Christine.Ferguson@surgery.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Scali, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Name
UF Health---Vascular Surgery
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Inflammation and Protein Restriction
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