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出境医 / 临床实验 / Inflammation and Protein Restriction
Inflammation and Protein Restriction
Study Description
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Protein Restriction Diet Inflammation | Other: 4 Day Protein Restricted Diet | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity |
| Actual Study Start Date : | September 9, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Protein Restriction Group
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.
|
Other: 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.
Other Name: Scandishake
|
Outcome Measures
Primary Outcome Measures :
- Change in inflammatory cell composition [ Time Frame: Day 2; Day 4; Day 7; Day 14 ]A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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, 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
Contacts and Locations
Contacts
| Contact: Salvatore Scali, MD | 352-273-5484 | salvatore.scali@surgery.ufl.edu | |
| Contact: Christine Ferguson | 352.548.6217 | Christine.Ferguson@surgery.ufl.edu |
Locations
| United States, Florida | |
| Malcom Randall VA Medical Center | Recruiting |
| Gainesville, Florida, United States, 32608 | |
| UF Health---Vascular Surgery | Recruiting |
| Gainesville, Florida, United States, 32611 | |
Sponsors and Collaborators
University of Florida
Malcom Randall VA Medical Center
Investigators
| Principal Investigator: | Salvatore Scali, MD | University of Florida |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 21, 2019 | ||||||||
| First Posted Date ICMJE | June 24, 2019 | ||||||||
| Last Update Posted Date | March 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | September 9, 2019 | ||||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in inflammatory cell composition [ Time Frame: Day 2; Day 4; Day 7; Day 14 ] A shift in the inflammatory cell composition as measured by the 10x single cell genomic analysis
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Inflammation and Protein Restriction | ||||||||
| Official Title ICMJE | Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Other: 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.
Other Name: Scandishake
|
||||||||
| Study Arms ICMJE | Experimental: Protein Restriction Group
Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided.
Intervention: Other: 4 Day Protein Restricted Diet
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE |
15 | ||||||||
| Estimated Study Completion Date ICMJE | June 2021 | ||||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03995979 | ||||||||
| Other Study ID Numbers ICMJE | IRB201900988 -V NF/SGVHS ( Other Identifier: Malcom Randall VA Medical Center ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Florida | ||||||||
| Study Sponsor ICMJE | University of Florida | ||||||||
| Collaborators ICMJE | Malcom Randall VA Medical Center | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Florida | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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