Inflammation and Protein Restriction

Not Applicable

Completed

• Conditions: Inflammation; Protein Restriction; Diet
• Interventions: Other: 4 Day Protein Restricted Diet

• Registration Number: NCT03995979
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-09-09
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Results First Submitted: 2024-06-12
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Results First Posted: 2024-12-24
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy volunteers between 18 and 70 years of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protein Restriction Group	4 Day Protein Restricted Diet	Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.

Primary Outcome Measures

Name	Time	Method
Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.	Day 2; Day 4; Day 7	Genomic sequencing along with taxonomic and functional pathways analysis is used to identify any compositional and functional changes in the intestinal microbiome of patients on short-term dietary restrictions in relation its anti-inflammatory effects on pre-operative conditioning,

Trial Locations

Locations (2)

Malcom Randall VA Medical Center; 🇺🇸 Gainesville, Florida, United States

UF Health---Vascular Surgery; 🇺🇸 Gainesville, Florida, United States