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

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ClinicalTrials.gov Identifier: NCT02867605
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Carol De La Motte, The Cleveland Clinic

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.

Condition or disease Intervention/treatment
Gastrointestinal Microbiome Dietary Supplement: Hyaluronan

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : July 2016
Actual Primary Completion Date : September 20, 2017
Estimated Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Controls ages 18-45 with BMI of 19-25 or 30-35 Dietary Supplement: Hyaluronan



Primary Outcome Measures :
  1. Change from baseline stool micro biome diversity and phylogenetic distribution at 8 days and 28 days [ Time Frame: Baseline, Day 8, Day 28 ]
  2. Change from baseline comprehensive metabolic panel and complete blood count at day 8 and 28 [ Time Frame: Baseline, Day 8, Day 28 ]
    Change in CMP (comprehensive metabolic panel), CBC (complete blood count) levels at 8 days and 28 days after baseline

  3. Change from baseline indirect calorimetry at 8 days and 28 days [ Time Frame: Baseline, Day 8, Day 28 ]
    Change in respiratory quotient at 8 days and 28 days after baseline

  4. Change from baseline fecal intestinal antimicrobial peptide secretion at 8 days and 28 days [ Time Frame: Baseline, Day 8, Day 28 ]
    Change in calprotectin, human beta-defensin at 8 days and 28 days after baseline

  5. Change from baseline serum indicators of intestinal permeability at 8 days and 28 days [ Time Frame: Baseline, Day 8, Day 28 ]
    Change in serum hyaluronan, Serum LPS (Lipopolysaccharide), Serum I-FABP ( liver fatty acid binding protein ) at 8 days and 28 days after baseline

  6. Change from baseline serum indicators of inflammation and injury at 8 days and 28 days. [ Time Frame: Baseline, Day 8, Day 28 ]
    Change in high-sensitivity C-Reactive Protein, IL6 (interleukin 6), and TNF (Tumor necrosis factor alpha) at 8 days and 28 days after baseline



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Twenty healthy adult volunteers, ten with a lean BMI between 19-25 and ten with an obese BMI between 30-35, will complete this study. There will be no restriction to gender or race. Age limits will be 18-45 years for this pilot study, since ageing may affect intestinal immunity, microbiome composition, prevalence of pre-clinical disease confounders
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867605


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic

Publications:
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Responsible Party: Carol De La Motte, Assoiciate Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02867605     History of Changes
Other Study ID Numbers: 16-142
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents