Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls ages 18-45 with BMI of 19-25 or 30-35 | Other | Single Arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronan | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 8, Day 28 |
| 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 | 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 | Baseline, Day 8, Day 28 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22761444 | Background | Hill DR, Kessler SP, Rho HK, Cowman MK, de la Motte CA. Specific-sized hyaluronan fragments promote expression of human beta-defensin 2 in intestinal epithelium. J Biol Chem. 2012 Aug 31;287(36):30610-24. doi: 10.1074/jbc.M112.356238. Epub 2012 Jul 3. | |
| 23950179 | Background | Hill DR, Rho HK, Kessler SP, Amin R, Homer CR, McDonald C, Cowman MK, de la Motte CA. Human milk hyaluronan enhances innate defense of the intestinal epithelium. J Biol Chem. 2013 Oct 4;288(40):29090-104. doi: 10.1074/jbc.M113.468629. Epub 2013 Aug 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35 | Hyaluronan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35 | Hyaluronan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | Posted | Mean | Standard Deviation | ratio | Baseline, Day 8, Day 28 |
|
0-28 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Day 0 | Baseline/Pre Treatment | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol De la Motte | Cleveland Clinic Foundation | 216 444-5374 | delamoc@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2020 | Aug 19, 2020 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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. | Baseline, day 8, and day 28 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
28 days post treatment |
|
|
| Primary | Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide | Posted | Mean | Standard Deviation | L/min | Baseline, Day 8, Day 28 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ratio | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein | Posted | Mean | Standard Deviation | ug/mL | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 | Posted | Mean | Standard Deviation | ng/ug | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan | Posted | Mean | Standard Deviation | ng/mL | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) | Posted | Mean | Standard Deviation | pg/mL | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein | Posted | Mean | Standard Deviation | g/dL | Baseline, Day 8, Day 28 |
|
|
|
| Primary | Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 | Posted | Mean | Standard Deviation | g/dL | Baseline, day 8 day 28 |
|
|
|
| Primary | White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 | Posted | Mean | Standard Deviation | k/uL | baseline, day 8, and day 28 |
|
|
|
| Primary | Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 | Posted | Mean | Standard Deviation | U/L | baseline, day 8, and day 28 |
|
|
|
| Primary | Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 | Posted | Mean | Standard Deviation | mmol/L | baseline, day 8, and day 28 |
|
|
|
| Primary | Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 | Posted | Mean | Standard Deviation | kilocalories/day | Baseline, day 8, and day 28 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percent of age/gender predicted values | Baseline, day 8, and day 28 |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Day 8 | Immediately post 7 day treatment | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Day 28 | 28 days post treatment | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
|
| Glucose |
|
| blood urea nitrogen |
|
| Creatinine |
|
|
|
|
|
|
| Albumin |
|
|
|
| alanine transaminase |
|
|
| carbon dioxide |
|
|