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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Hyaluronan

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Controls ages 18-45 with BMI of 19-25 or 30-35; Single Arm study	Dietary supplement: Hyaluronan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 16-142