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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Cleveland Clinic Foundation
Cleveland, Ohio, United States
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
Time frame: Baseline, Day 8, Day 28
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Time frame: Baseline, Day 8, Day 28
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
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
Time frame: Baseline, Day 8, Day 28
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
Time frame: Baseline, Day 8, Day 28
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
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
Time frame: Baseline, Day 8, Day 28
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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
Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
Time frame: Baseline, Day 8, Day 28
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Time frame: Baseline, day 8 day 28
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
Time frame: baseline, day 8, and day 28
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
Time frame: baseline, day 8, and day 28
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
Time frame: baseline, day 8, and day 28
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
Time frame: 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.
Time frame: Baseline, day 8, and day 28