Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03995979
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2019-06-21
Brief Title:
Inflammation and Protein Restriction
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NFSGVHS | OTHER | Malcom Randall VA Medical Center | None |