Clinical trial NCT02867605: Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Microbiome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
timeFrame: Baseline, Day 8, Day 28
measure: Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
timeFrame: Baseline, Day 8, Day 28
measure: Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
timeFrame: Baseline, Day 8, Day 28
measure: Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
timeFrame: Baseline, Day 8, Day 28
measure: Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
timeFrame: Baseline, Day 8, Day 28
measure: Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
timeFrame: Baseline, Day 8, Day 28
measure: Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
timeFrame: Baseline, Day 8, Day 28
measure: Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
timeFrame: Baseline, Day 8, Day 28
measure: Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
timeFrame: Baseline, Day 8, Day 28
measure: Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
timeFrame: Baseline, day 8 day 28
measure: White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
timeFrame: baseline, day 8, and day 28
measure: Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
timeFrame: baseline, day 8, and day 28
measure: Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
timeFrame: baseline, day 8, and day 28
measure: Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
timeFrame: Baseline, day 8, and day 28
measure: Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
timeFrame: Baseline, day 8, and day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
citation: 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.
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.