N/A
N=20
Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
Gastrointestinal Microbiome
Bottom Line
View on ClinicalTrials.gov: NCT02867605 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days — 0.697; 0.722; 0.735; 0.146 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyaluronan (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days |
0.697; 0.722; 0.735; 0.146; 0.145; 0.141 | — |
| PRIMARY Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine |
9.2; 9.2; 9.1; 0.4; 0.4; 0.4 | — |
| PRIMARY Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide |
0.225; 0.224; 0.239; 0.180; 0.184; 0.197 | — |
| PRIMARY Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ |
0.808; 0.822; 0.826 | — |
| PRIMARY Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein |
22883.8; 22365.3; 22726.3 | — |
| PRIMARY Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2 |
0.00627; 0.00828; 0.00891; 0.0042; 0.00535; 0.00362 | — |
| PRIMARY Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan |
0.409; 2.677; 1.256; 338.8; 329.0; 338.7 | — |
| PRIMARY Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6) |
2.0; 2.4; 3.2; 9.6; 11.7; 10.5 | — |
| PRIMARY Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein |
10.2; 10.3; 11.6 | — |
| PRIMARY Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28 |
13.4; 13.4; 13.2; 7.4; 7.3; 7.3 | — |
| PRIMARY White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28 |
6.0; 6.1; 6.2; 263; 262; 271 | — |
| PRIMARY Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28 |
66; 66; 67; 18; 22; 19 | — |
| PRIMARY Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28 |
140; 140; 140; 4.0; 4.1; 4.0 | — |
| PRIMARY Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28 |
1556.3; 1562.8; 1670.6; 1653.1; 1665.2; 1668.4 | — |
| PRIMARY Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28 |
95.89; 95.67; 101.39 | — |
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
Data sourced from ClinicalTrials.gov (NCT02867605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.