Inflammation and Protein Restriction

NCT03995979 | Completed Results DMC

• 2 other identifiers: IRB201900988 -VNF/SGVHS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Conditions

Protein Restriction; Diet; Inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.

  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,

  Day 2; Day 4; Day 7

Study Arms (1)

Protein Restriction Group

EXPERIMENTAL

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

Interventions

4 Day Protein Restricted Diet 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.

Also known as: Scandishake

Protein Restriction Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers between 18 and 70 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Malcom Randall VA Medical Center: collaborator

Study Sites (2)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

UF Health---Vascular Surgery

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

The specific diet used in this study,although advantageous for its feasibility in achieving the targeted percent protein goal and caloric restriction, may deviate from the ideal short-term protein-calorie dietary restriction (stDR). Moreover, observations could be attributed to the diet itself and not necessarily from protein or caloric restrictions. Lastly, this study lacks a description of the peripheral immune cell response.

Results Point of Contact

• Title: Dr. Salvatore Scali
• Organization: University of Florida

salvatore.scali@surgery.ufl.edu

(352) 376-1611

Study Officials

• Salvatore Scali, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: September 9, 2019
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)