N/A
Completed N=12
Inflammation and Protein Restriction
Protein Restriction · Diet · Inflammation
Source: ClinicalTrials.gov NCT03995979 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: 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
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
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 |
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
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. Informational only — not medical advice.