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

Not Applicable

Completed

Conditions: Gastrointestinal Microbiome

Interventions: Dietary Supplement: Hyaluronan

Registration Number: NCT02867605

Lead Sponsor: The Cleveland Clinic

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Controls ages 18-45 with BMI of 19-25 or 30-35	Hyaluronan	Single Arm study

Primary Outcome Measures

Name	Time	Method
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
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
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 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
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide	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
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28	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
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28	baseline, day 8, and 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
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.