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Inflammation and Protein Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03995979
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 11, 2020
Malcom Randall VA Medical Center
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Protein Restriction Diet Inflammation Other: 4 Day Protein Restricted Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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 : September 9, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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 Name: Scandishake

Primary Outcome Measures :
  1. Change in inflammatory cell composition [ Time Frame: Day 2; Day 4; Day 7; Day 14 ]
    A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03995979

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Contact: Salvatore Scali, MD 352-273-5484
Contact: Christine Ferguson 352.548.6217

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United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
UF Health---Vascular Surgery Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Malcom Randall VA Medical Center
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Principal Investigator: Salvatore Scali, MD University of Florida
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Responsible Party: University of Florida Identifier: NCT03995979    
Other Study ID Numbers: IRB201900988 -V
NF/SGVHS ( Other Identifier: Malcom Randall VA Medical Center )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes