Diet, Inflammation, Protein Restriction
Conditions
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 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.
Interventions
OTHER4 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.
Sponsors
Malcom Randall VA Medical Center
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Day 2; Day 4; Day 7 | 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, |
Countries
United States
Participant flow
Recruitment details
Healthy, young adult males and females free of chronic medical conditions were recruited to participate in this study. Informed consent was obtained from all subjects before study participation, and this study was approved by the University of Florida's institutional review board (UF IRB#201900988). Advertisements were created for the general public for recruitment of participants with no clinical relationship.
Pre-assignment details
Of 12 enrolled participants, 10 met inclusion criteria and commenced study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Protein Restriction Group Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.
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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Protein Restriction Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 28.2 years STANDARD_DEVIATION 9.2 |
| Body Mass Index | 24.7 kg/m2 STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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,
Time frame: Day 2; Day 4; Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Differential expression of genes on Day 2 of DR compared to baseline | 232 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Differential expression of genes on day 4 DR compared to baseline | 172 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Differential expression of genes on day 7 DR compared to baseline | 145 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Total genes upregulated on day 2 of DR | 93 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Total genes upregulated on day 4 of DR | 24 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Total genes upregulated on day 7 of DR | 85 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Total genes downregulated on day 2 of DR | 139 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Total genes downregulated on day 4 of DR | 148 Number of immunity related genes |
| Protein Restriction Group | Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment. | Total genes downregulated on day 7 of DR | 60 Number of immunity related genes |
Comparison: A compositional analysis with species-level alpha diversity will be performed between the three conditions (Pre-Dietary Restriction, Dietary Restriction, and Post-Dietary Restriction,) with ANOVA testing. Furthermore, a differential abundance analysis will be performed to further identify and confirm prevalent organisms associated with the experimental dietary restriction.p-value: 0.05Paired t-test