Inflammation and Protein Restriction

NCT ID: NCT03995979

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2024-02-16

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.

Conditions

Protein Restriction; Diet; Inflammation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Protein Restriction Group

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

Group Type: EXPERIMENTAL

4 Day Protein Restricted Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Scandishake

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, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malcom Randall VA Medical Center

FED

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Scali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Malcom Randall VA Medical Center

Gainesville, Florida, United States

UF Health---Vascular Surgery

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NF/SGVHS

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201900988 -V

Identifier Type: -

Identifier Source: org_study_id