Trial Outcomes & Findings for Inflammation and Protein Restriction (NCT NCT03995979)
NCT ID: NCT03995979
Last Updated: 2024-12-24
Results Overview
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,
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Day 2; Day 4; Day 7
Results posted on
2024-12-24
Participant Flow
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.
Of 12 enrolled participants, 10 met inclusion criteria and commenced study intervention.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Protein Restriction Group
n=10 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants • 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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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants • 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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Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • 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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Age, Continuous
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28.2 years
STANDARD_DEVIATION 9.2 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants • 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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Sex: Female, Male
Male
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5 Participants
n=5 Participants • 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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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants • 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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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants • 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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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants • 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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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants • 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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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants • 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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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants • 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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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants • 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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Race (NIH/OMB)
White
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6 Participants
n=5 Participants • 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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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants • 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.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • 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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Region of Enrollment
United States
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10 participants
n=5 Participants • 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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Body Mass Index
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24.7 kg/m2
STANDARD_DEVIATION 4.0 • n=5 Participants • 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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PRIMARY outcome
Timeframe: Day 2; Day 4; Day 7Genomic 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,
Outcome measures
| Measure |
Protein Restriction Group
n=10 Participants
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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|---|---|
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Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
Total genes upregulated on day 4 of DR
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24 Number of immunity related genes
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Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
Total genes upregulated on day 7 of DR
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85 Number of immunity related genes
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Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
Total genes downregulated on day 2 of DR
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139 Number of immunity related genes
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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
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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
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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
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232 Number of immunity related genes
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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
|
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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
|
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Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
Total genes upregulated on day 2 of DR
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93 Number of immunity related genes
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Adverse Events
Protein Restriction Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place