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

Gastrointestinal Microbiome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867605
• Other study ID #: 16-142
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 20, 2019

Study information

• Verified date: August 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 20, 2019
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome

Intervention

Dietary Supplement:
• Hyaluronan

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hill DR, Kessler SP, Rho HK, Cowman MK, de la Motte CA. Specific-sized hyaluronan fragments promote expression of human ß-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline, Day 8, Day 28
Primary	Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine		Baseline, Day 8, Day 28
Primary	Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide		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	Baseline, Day 8, Day 28
Primary	Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein		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		Baseline, Day 8, Day 28
Primary	Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan		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)		Baseline, Day 8, Day 28
Primary	Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein		Baseline, Day 8, Day 28
Primary	Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28		Baseline, day 8 day 28
Primary	White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28		baseline, day 8, and day 28
Primary	Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28		baseline, day 8, and day 28
Primary	Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28		baseline, day 8, and day 28
Primary	Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28		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.	Baseline, day 8, and day 28