N/A N=12 Basic Science

Inflammation and Protein Restriction

Protein Restriction · Diet · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT03995979 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. — 232; 172; 145; 93 Number of immunity related genes — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 4 Day Protein Restricted Diet (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.	232; 172; 145; 93; 24; 85	0.05

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03995979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.