Skip to main content
OpenTrials
Completed

NCT Number: NCT02867605

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Microbiome

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronan

Dietary Supplement

Primary outcomes

  1. Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days

    Time frame: Baseline, Day 8, Day 28

    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

  2. Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine

    Time frame: Baseline, Day 8, Day 28

  3. Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide

    Time frame: Baseline, Day 8, Day 28

  4. Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ

    Time frame: Baseline, Day 8, Day 28

    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

  5. Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein

    Time frame: Baseline, Day 8, Day 28

  6. Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2

    Time frame: Baseline, Day 8, Day 28

  7. Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan

    Time frame: Baseline, Day 8, Day 28

  8. Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)

    Time frame: Baseline, Day 8, Day 28

  9. Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein

    Time frame: Baseline, Day 8, Day 28

  10. Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28

    Time frame: Baseline, day 8 day 28

  11. White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28

    Time frame: baseline, day 8, and day 28

  12. Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28

    Time frame: baseline, day 8, and day 28

  13. Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28

    Time frame: baseline, day 8, and day 28

  14. Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28

    Time frame: Baseline, day 8, and day 28

  15. Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Aug 16, 2016
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.