Gastrointestinal Microbiome
Conditions
Brief summary
The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of HA35.
Interventions
DIETARY_SUPPLEMENTHyaluronan
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 19-25 (lean), and BMI 30-35 (obese) * Age 18-45 years old * Willingness to take oral supplement and adhere to study requirements
Exclusion criteria
* Diabetes * Oral antibiotics within 4 weeks of study initiation * History of cardiac disease, and medications for cardiac disease * Use statins and antihypertensive drugs * Inflammatory bowel disease including irritable bowel syndrome * History of intestinal surgery, excluding hernia repair and appendectomy * Active cancer diagnosis (except skin cancer) * Chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists) * Immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs) * Vegetarian or vegan diet7 * Abnormal liver or kidney function as measured by routine serum chemistry testing * Severe anemia or significant white blood cell or platelet abnormalities * No additional blood or blood product donations during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | Baseline, Day 8, Day 28 | Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. As an example a relative abundance of firmicutes equal to 0.9 would mean that 90% of the bacteria identified in a sample are firmicutes |
| Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Baseline, Day 8, Day 28 | — |
| Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | Baseline, Day 8, Day 28 | — |
| Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ | Baseline, Day 8, Day 28 | The respiratory quotient is a ratio between the volume of carbon dioxide exhaled and the volume of oxygen inhaled during respiration. It typically ranges between 0.7 and 1.0 and is an indicator of metabolic fuel or substrate use in tissues; it must be calculated under resting or steady-state exercise conditions. A ratio of 0.7 is indicative of mixed fat use, whereas a ratio of 1.0 indicates the exclusive use of carbohydrates |
| Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein | Baseline, Day 8, Day 28 | — |
| Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | Baseline, Day 8, Day 28 | — |
| Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Baseline, Day 8, Day 28 | — |
| Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | Baseline, Day 8, Day 28 | — |
| Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein | Baseline, Day 8, Day 28 | — |
| Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Baseline, day 8 day 28 | — |
| White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | baseline, day 8, and day 28 | — |
| Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | baseline, day 8, and day 28 | — |
| Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | baseline, day 8, and day 28 | — |
| Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Baseline, day 8, and day 28 | — |
| Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28 | Baseline, day 8, and day 28 | This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35 Hyaluronan | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35 |
|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
Time frame: baseline, day 8, and day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | aspartate transaminase | 18 U/L | Standard Deviation 6 |
| Day 0 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | Alkaline Phosphatase | 66 U/L | Standard Deviation 16 |
| Day 0 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | alanine transaminase | 16 U/L | Standard Deviation 7 |
| Day 8 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | aspartate transaminase | 22 U/L | Standard Deviation 18 |
| Day 8 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | Alkaline Phosphatase | 66 U/L | Standard Deviation 17 |
| Day 8 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | alanine transaminase | 15 U/L | Standard Deviation 6 |
| Day 28 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | Alkaline Phosphatase | 67 U/L | Standard Deviation 17 |
| Day 28 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | alanine transaminase | 18 U/L | Standard Deviation 17 |
| Day 28 | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | aspartate transaminase | 19 U/L | Standard Deviation 7 |
Primary
Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Day 0 | Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein | 10.2 g/dL | Standard Deviation 15.5 |
| Day 8 | Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein | 10.3 g/dL | Standard Deviation 12.8 |
| Day 28 | Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein | 11.6 g/dL | Standard Deviation 13.7 |
Primary
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Time frame: Baseline, day 8 day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Protein | 7.4 g/dL | Standard Deviation 0.3 |
| Day 0 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Hemoglobin | 13.4 g/dL | Standard Deviation 1.5 |
| Day 0 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Albumin | 4.4 g/dL | Standard Deviation 0.3 |
| Day 8 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Protein | 7.3 g/dL | Standard Deviation 0.4 |
| Day 8 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Hemoglobin | 13.4 g/dL | Standard Deviation 1.4 |
| Day 8 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Albumin | 4.4 g/dL | Standard Deviation 0.3 |
| Day 28 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Hemoglobin | 13.2 g/dL | Standard Deviation 1.5 |
| Day 28 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Albumin | 4.3 g/dL | Standard Deviation 0.3 |
| Day 28 | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Protein | 7.3 g/dL | Standard Deviation 0.4 |
Primary
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. As an example a relative abundance of firmicutes equal to 0.9 would mean that 90% of the bacteria identified in a sample are firmicutes
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | verrucomicrobia | 0.0415 ratio | Standard Deviation 0.117 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | others | 0.000359 ratio | Standard Deviation 0.000589 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | euryarchaeota | 0.00381 ratio | Standard Deviation 0.00797 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | proteobacteria | 0.0111 ratio | Standard Deviation 0.0211 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | firmicutes | 0.697 ratio | Standard Deviation 0.164 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | unclassified | 0.000272 ratio | Standard Deviation 0.00000633 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | bacteroidetes | 0.0969 ratio | Standard Deviation 0.0855 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | actinobacteria | 0.146 ratio | Standard Deviation 0.0985 |
| Day 0 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | tenericutes | 0.00275 ratio | Standard Deviation 0.00605 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | proteobacteria | 0.00789 ratio | Standard Deviation 0.0118 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | firmicutes | 0.722 ratio | Standard Deviation 0.133 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | actinobacteria | 0.145 ratio | Standard Deviation 0.111 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | bacteroidetes | 0.00789 ratio | Standard Deviation 0.0497 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | verrucomicrobia | 0.0398 ratio | Standard Deviation 0.115 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | euryarchaeota | 0.00295 ratio | Standard Deviation 0.00558 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | tenericutes | 0.00267 ratio | Standard Deviation 0.00602 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | unclassified | 0.000243 ratio | Standard Deviation 0.00000618 |
| Day 8 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | others | 0.000134 ratio | Standard Deviation 0.000247 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | bacteroidetes | 0.101 ratio | Standard Deviation 0.102 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | firmicutes | 0.735 ratio | Standard Deviation 0.118 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | tenericutes | 0.00152 ratio | Standard Deviation 0.00322 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | actinobacteria | 0.141 ratio | Standard Deviation 0.0951 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | others | 0.000183 ratio | Standard Deviation 0.00031 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | proteobacteria | 0.00432 ratio | Standard Deviation 0.00509 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | verrucomicrobia | 0.0151 ratio | Standard Deviation 0.0273 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | unclassified | 0.000237 ratio | Standard Deviation 0.00000733 |
| Day 28 | Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days | euryarchaeota | 0.00221 ratio | Standard Deviation 0.00463 |
Primary
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | calprotectin | 0.00627 ng/ug | Standard Deviation 0.0033 |
| Day 0 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | human beta-Defensin2 | 0.0042 ng/ug | Standard Deviation 0.0066 |
| Day 8 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | calprotectin | 0.00828 ng/ug | Standard Deviation 0.005886 |
| Day 8 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | human beta-Defensin2 | 0.00535 ng/ug | Standard Deviation 0.01046 |
| Day 28 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | calprotectin | 0.00891 ng/ug | Standard Deviation 0.00557 |
| Day 28 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | human beta-Defensin2 | 0.00362 ng/ug | Standard Deviation 0.00814 |
Primary
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Day 0 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein | 22883.8 ug/mL | Standard Deviation 6425.7 |
| Day 8 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein | 22365.3 ug/mL | Standard Deviation 5872.8 |
| Day 28 | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein | 22726.3 ug/mL | Standard Deviation 6305.2 |
Primary
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
The respiratory quotient is a ratio between the volume of carbon dioxide exhaled and the volume of oxygen inhaled during respiration. It typically ranges between 0.7 and 1.0 and is an indicator of metabolic fuel or substrate use in tissues; it must be calculated under resting or steady-state exercise conditions. A ratio of 0.7 is indicative of mixed fat use, whereas a ratio of 1.0 indicates the exclusive use of carbohydrates
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Day 0 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ | 0.808 ratio | Standard Deviation 0.077 |
| Day 8 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ | 0.822 ratio | Standard Deviation 0.061 |
| Day 28 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ | 0.826 ratio | Standard Deviation 0.0708 |
Primary
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | volume oxygen | 0.225 L/min | Standard Deviation 0.041 |
| Day 0 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | volume carbon dioxide | 0.180 L/min | Standard Deviation 0.029 |
| Day 8 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | volume oxygen | 0.224 L/min | Standard Deviation 0.039 |
| Day 8 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | volume carbon dioxide | 0.184 L/min | Standard Deviation 0.035 |
| Day 28 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | volume oxygen | 0.239 L/min | Standard Deviation 0.048 |
| Day 28 | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | volume carbon dioxide | 0.197 L/min | Standard Deviation 0.038 |
Primary
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Bilirubin (total) | 0.4 mg/dL | Standard Deviation 0.3 |
| Day 0 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Creatinine | 0.85 mg/dL | Standard Deviation 0.16 |
| Day 0 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Calcium | 9.2 mg/dL | Standard Deviation 0.4 |
| Day 0 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Glucose | 92 mg/dL | Standard Deviation 20 |
| Day 0 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | blood urea nitrogen | 11 mg/dL | Standard Deviation 3 |
| Day 8 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Glucose | 94 mg/dL | Standard Deviation 16 |
| Day 8 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | blood urea nitrogen | 11 mg/dL | Standard Deviation 4 |
| Day 8 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Creatinine | 0.85 mg/dL | Standard Deviation 0.16 |
| Day 8 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Bilirubin (total) | 0.4 mg/dL | Standard Deviation 0.2 |
| Day 8 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Calcium | 9.2 mg/dL | Standard Deviation 0.2 |
| Day 28 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Creatinine | 0.83 mg/dL | Standard Deviation 0.15 |
| Day 28 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Calcium | 9.1 mg/dL | Standard Deviation 0.3 |
| Day 28 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Bilirubin (total) | 0.4 mg/dL | Standard Deviation 0.3 |
| Day 28 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Glucose | 89 mg/dL | Standard Deviation 27 |
| Day 28 | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | blood urea nitrogen | 12 mg/dL | Standard Deviation 3 |
Primary
Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race.
Time frame: Baseline, day 8, and day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Day 0 | Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28 | 95.89 percent of age/gender predicted values | Standard Deviation 9.48 |
| Day 8 | Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28 | 95.67 percent of age/gender predicted values | Standard Deviation 12.94 |
| Day 28 | Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28 | 101.39 percent of age/gender predicted values | Standard Deviation 10.41 |
Primary
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
Time frame: Baseline, day 8, and day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Resting Energy Expenditure | 1556.3 kilocalories/day | Standard Deviation 274.5 |
| Day 0 | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Metabolic Rate | 1653.1 kilocalories/day | Standard Deviation 268.7 |
| Day 8 | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Resting Energy Expenditure | 1562.8 kilocalories/day | Standard Deviation 221.4 |
| Day 8 | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Metabolic Rate | 1665.2 kilocalories/day | Standard Deviation 258.8 |
| Day 28 | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Resting Energy Expenditure | 1670.6 kilocalories/day | Standard Deviation 333.9 |
| Day 28 | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Metabolic Rate | 1668.4 kilocalories/day | Standard Deviation 259.8 |
Primary
Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | TNF alpha | 2.0 pg/mL | Standard Deviation 5.1 |
| Day 0 | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | interleukin 6 (IL-6) | 9.6 pg/mL | Standard Deviation 14.6 |
| Day 8 | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | TNF alpha | 2.4 pg/mL | Standard Deviation 6.6 |
| Day 8 | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | interleukin 6 (IL-6) | 11.7 pg/mL | Standard Deviation 16.8 |
| Day 28 | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | TNF alpha | 3.2 pg/mL | Standard Deviation 6.9 |
| Day 28 | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | interleukin 6 (IL-6) | 10.5 pg/mL | Standard Deviation 14.6 |
Primary
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
Time frame: Baseline, Day 8, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Lipopolysaccharide | 0.409 ng/mL | Standard Deviation 1.347 |
| Day 0 | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Hyaluronan | 338.8 ng/mL | Standard Deviation 82.8 |
| Day 8 | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Lipopolysaccharide | 2.677 ng/mL | Standard Deviation 5.959 |
| Day 8 | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Hyaluronan | 329.0 ng/mL | Standard Deviation 106.6 |
| Day 28 | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Lipopolysaccharide | 1.256 ng/mL | Standard Deviation 4.029 |
| Day 28 | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Hyaluronan | 338.7 ng/mL | Standard Deviation 73.9 |
Primary
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
Time frame: baseline, day 8, and day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Potassium | 4.0 mmol/L | Standard Deviation 0.2 |
| Day 0 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Sodium | 140 mmol/L | Standard Deviation 1 |
| Day 0 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | carbon dioxide | 25 mmol/L | Standard Deviation 2 |
| Day 8 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Potassium | 4.1 mmol/L | Standard Deviation 0.3 |
| Day 8 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Sodium | 140 mmol/L | Standard Deviation 2 |
| Day 8 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | carbon dioxide | 24 mmol/L | Standard Deviation 2 |
| Day 28 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Sodium | 140 mmol/L | Standard Deviation 2 |
| Day 28 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | carbon dioxide | 24 mmol/L | Standard Deviation 2 |
| Day 28 | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Potassium | 4.0 mmol/L | Standard Deviation 0.2 |
Primary
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
Time frame: baseline, day 8, and day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 0 | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | White Blood Cell | 6.0 k/uL | Standard Deviation 1.6 |
| Day 0 | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | Platelet Count | 263 k/uL | Standard Deviation 59 |
| Day 8 | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | White Blood Cell | 6.1 k/uL | Standard Deviation 1.4 |
| Day 8 | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | Platelet Count | 262 k/uL | Standard Deviation 63 |
| Day 28 | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | White Blood Cell | 6.2 k/uL | Standard Deviation 1.5 |
| Day 28 | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | Platelet Count | 271 k/uL | Standard Deviation 64 |