Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health

Study Overview
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Brief Summary
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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.

Conditions
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Gastrointestinal Microbiome

Intervention / Treatment
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* Dietary Supplement: Hyaluronan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Controls ages 18-45 with BMI of 19-25 or 30-35<br>Single Arm study | Dietary Supplement: Hyaluronan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 |