Inflammation and Protein Restriction

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995979
• Other study ID #: IRB201900988 -V
• Secondary ID: NF/SGVHS
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: February 16, 2024

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet
• Inflammation
• Protein Restriction

Intervention

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.

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	UF Health---Vascular Surgery	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Malcom Randall VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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