NCT02867605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 13, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 9, 2016

Results QC Date

February 21, 2020

Last Update Submit

August 19, 2020

Conditions

Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (15)

  • 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

Study Arms (1)

Healthy Controls ages 18-45 with BMI of 19-25 or 30-35

OTHER

Single Arm study

Dietary Supplement: Hyaluronan

Interventions

HyaluronanDIETARY_SUPPLEMENT
Healthy Controls ages 18-45 with BMI of 19-25 or 30-35

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19-25 (lean), and BMI 30-35 (obese)
  • Age 18-45 years old
  • Willingness to take oral supplement and adhere to study requirements

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

  • 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.

    PMID: 22761444BACKGROUND

  • 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.

    PMID: 23950179BACKGROUND

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Dr. Carol De la Motte
Organization
Cleveland Clinic Foundation
delamoc@ccf.org
216 444-5374

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoiciate Staff

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 16, 2016

Study Start

July 1, 2016

Primary Completion

September 20, 2017

Study Completion

June 20, 2019

Last Updated

September 3, 2020

Results First Posted

August 13, 2020

Record last verified: 2020-08

Locations

US(1)