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| ID | Type | Description | Link |
|---|---|---|---|
| NF/SGVHS | Other Identifier | Malcom Randall VA Medical Center |
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| Name | Class |
|---|---|
| Malcom Randall VA Medical Center | FED |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Restriction Group | Experimental | Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Scali, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | United States | ||
| UF Health---Vascular Surgery |
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Of 12 enrolled participants, 10 met inclusion criteria and commenced study intervention.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, | Posted | Number | Number of immunity related genes | Day 2; Day 4; Day 7 |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Salvatore Scali | University of Florida | (352) 376-1611 | salvatore.scali@surgery.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2019 | Jun 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2023 | Jun 12, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2023 | Jun 7, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
|
| Gainesville |
| Florida |
| 32611 |
| United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced. | Count of Participants | Participants |
|
| Region of Enrollment | 10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced. | Number | participants |
|
| Body Mass Index | 10 healthy individuals were recruited to participate in the study: five males and five females. Originally, 12 participants in total agreed to participate in the study following completion of the informed consent form, but two were withdrawn before the study procedural commenced. | Mean | Standard Deviation | kg/m2 |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |