Trial Outcomes & Findings for Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health (NCT NCT02867605)
NCT ID: NCT02867605
Last Updated: 2020-09-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline, Day 8, Day 28
Results posted on
2020-09-03
Participant Flow
Participant milestones
| Measure |
Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35
Hyaluronan
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
Baseline characteristics by cohort
| Measure |
Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35
n=20 Participants
Hyaluronan
|
|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Relative 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
Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
verrucomicrobia
|
0.0415 ratio
Standard Deviation 0.117
|
0.0398 ratio
Standard Deviation 0.115
|
0.0151 ratio
Standard Deviation 0.0273
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
firmicutes
|
0.697 ratio
Standard Deviation 0.164
|
0.722 ratio
Standard Deviation 0.133
|
0.735 ratio
Standard Deviation 0.118
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
actinobacteria
|
0.146 ratio
Standard Deviation 0.0985
|
0.145 ratio
Standard Deviation 0.111
|
0.141 ratio
Standard Deviation 0.0951
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
bacteroidetes
|
0.0969 ratio
Standard Deviation 0.0855
|
0.00789 ratio
Standard Deviation 0.0497
|
0.101 ratio
Standard Deviation 0.102
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
proteobacteria
|
0.0111 ratio
Standard Deviation 0.0211
|
0.00789 ratio
Standard Deviation 0.0118
|
0.00432 ratio
Standard Deviation 0.00509
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
euryarchaeota
|
0.00381 ratio
Standard Deviation 0.00797
|
0.00295 ratio
Standard Deviation 0.00558
|
0.00221 ratio
Standard Deviation 0.00463
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
tenericutes
|
0.00275 ratio
Standard Deviation 0.00605
|
0.00267 ratio
Standard Deviation 0.00602
|
0.00152 ratio
Standard Deviation 0.00322
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
unclassified
|
0.000272 ratio
Standard Deviation 0.00000633
|
0.000243 ratio
Standard Deviation 0.00000618
|
0.000237 ratio
Standard Deviation 0.00000733
|
|
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
others
|
0.000359 ratio
Standard Deviation 0.000589
|
0.000134 ratio
Standard Deviation 0.000247
|
0.000183 ratio
Standard Deviation 0.00031
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Calcium
|
9.2 mg/dL
Standard Deviation 0.4
|
9.2 mg/dL
Standard Deviation 0.2
|
9.1 mg/dL
Standard Deviation 0.3
|
|
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Bilirubin (total)
|
0.4 mg/dL
Standard Deviation 0.3
|
0.4 mg/dL
Standard Deviation 0.2
|
0.4 mg/dL
Standard Deviation 0.3
|
|
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Glucose
|
92 mg/dL
Standard Deviation 20
|
94 mg/dL
Standard Deviation 16
|
89 mg/dL
Standard Deviation 27
|
|
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
blood urea nitrogen
|
11 mg/dL
Standard Deviation 3
|
11 mg/dL
Standard Deviation 4
|
12 mg/dL
Standard Deviation 3
|
|
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Creatinine
|
0.85 mg/dL
Standard Deviation 0.16
|
0.85 mg/dL
Standard Deviation 0.16
|
0.83 mg/dL
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
volume oxygen
|
0.225 L/min
Standard Deviation 0.041
|
0.224 L/min
Standard Deviation 0.039
|
0.239 L/min
Standard Deviation 0.048
|
|
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
volume carbon dioxide
|
0.180 L/min
Standard Deviation 0.029
|
0.184 L/min
Standard Deviation 0.035
|
0.197 L/min
Standard Deviation 0.038
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28The 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
Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
|
0.808 ratio
Standard Deviation 0.077
|
0.822 ratio
Standard Deviation 0.061
|
0.826 ratio
Standard Deviation 0.0708
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
|
22883.8 ug/mL
Standard Deviation 6425.7
|
22365.3 ug/mL
Standard Deviation 5872.8
|
22726.3 ug/mL
Standard Deviation 6305.2
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
calprotectin
|
0.00627 ng/ug
Standard Deviation 0.0033
|
0.00828 ng/ug
Standard Deviation 0.005886
|
0.00891 ng/ug
Standard Deviation 0.00557
|
|
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
human beta-Defensin2
|
0.0042 ng/ug
Standard Deviation 0.00660
|
0.00535 ng/ug
Standard Deviation 0.01046
|
0.00362 ng/ug
Standard Deviation 0.00814
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
Lipopolysaccharide
|
0.409 ng/mL
Standard Deviation 1.347
|
2.677 ng/mL
Standard Deviation 5.959
|
1.256 ng/mL
Standard Deviation 4.029
|
|
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
Hyaluronan
|
338.8 ng/mL
Standard Deviation 82.8
|
329.0 ng/mL
Standard Deviation 106.6
|
338.7 ng/mL
Standard Deviation 73.9
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
TNF alpha
|
2.0 pg/mL
Standard Deviation 5.1
|
2.4 pg/mL
Standard Deviation 6.6
|
3.2 pg/mL
Standard Deviation 6.9
|
|
Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
interleukin 6 (IL-6)
|
9.6 pg/mL
Standard Deviation 14.6
|
11.7 pg/mL
Standard Deviation 16.8
|
10.5 pg/mL
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: Baseline, Day 8, Day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
|
10.2 g/dL
Standard Deviation 15.5
|
10.3 g/dL
Standard Deviation 12.8
|
11.6 g/dL
Standard Deviation 13.7
|
PRIMARY outcome
Timeframe: Baseline, day 8 day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Albumin
|
4.4 g/dL
Standard Deviation 0.3
|
4.4 g/dL
Standard Deviation 0.3
|
4.3 g/dL
Standard Deviation 0.3
|
|
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Hemoglobin
|
13.4 g/dL
Standard Deviation 1.5
|
13.4 g/dL
Standard Deviation 1.4
|
13.2 g/dL
Standard Deviation 1.5
|
|
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Protein
|
7.4 g/dL
Standard Deviation 0.3
|
7.3 g/dL
Standard Deviation 0.4
|
7.3 g/dL
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: baseline, day 8, and day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
White Blood Cell
|
6.0 k/uL
Standard Deviation 1.6
|
6.1 k/uL
Standard Deviation 1.4
|
6.2 k/uL
Standard Deviation 1.5
|
|
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
Platelet Count
|
263 k/uL
Standard Deviation 59
|
262 k/uL
Standard Deviation 63
|
271 k/uL
Standard Deviation 64
|
PRIMARY outcome
Timeframe: baseline, day 8, and day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
Alkaline Phosphatase
|
66 U/L
Standard Deviation 16
|
66 U/L
Standard Deviation 17
|
67 U/L
Standard Deviation 17
|
|
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
aspartate transaminase
|
18 U/L
Standard Deviation 6
|
22 U/L
Standard Deviation 18
|
19 U/L
Standard Deviation 7
|
|
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
alanine transaminase
|
16 U/L
Standard Deviation 7
|
15 U/L
Standard Deviation 6
|
18 U/L
Standard Deviation 17
|
PRIMARY outcome
Timeframe: baseline, day 8, and day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
Sodium
|
140 mmol/L
Standard Deviation 1
|
140 mmol/L
Standard Deviation 2
|
140 mmol/L
Standard Deviation 2
|
|
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
Potassium
|
4.0 mmol/L
Standard Deviation 0.2
|
4.1 mmol/L
Standard Deviation 0.3
|
4.0 mmol/L
Standard Deviation 0.2
|
|
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
carbon dioxide
|
25 mmol/L
Standard Deviation 2
|
24 mmol/L
Standard Deviation 2
|
24 mmol/L
Standard Deviation 2
|
PRIMARY outcome
Timeframe: Baseline, day 8, and day 28Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
Resting Energy Expenditure
|
1556.3 kilocalories/day
Standard Deviation 274.5
|
1562.8 kilocalories/day
Standard Deviation 221.4
|
1670.6 kilocalories/day
Standard Deviation 333.9
|
|
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
Metabolic Rate
|
1653.1 kilocalories/day
Standard Deviation 268.7
|
1665.2 kilocalories/day
Standard Deviation 258.8
|
1668.4 kilocalories/day
Standard Deviation 259.8
|
PRIMARY outcome
Timeframe: Baseline, day 8, and day 28This 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.
Outcome measures
| Measure |
Day 0
n=20 Participants
Baseline/Pre Treatment
|
Day 8
n=20 Participants
Immediately post 7 day treatment
|
Day 28
n=20 Participants
28 days post treatment
|
|---|---|---|---|
|
Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
|
95.89 percent of age/gender predicted values
Standard Deviation 9.48
|
95.67 percent of age/gender predicted values
Standard Deviation 12.94
|
101.39 percent of age/gender predicted values
Standard Deviation 10.41
|
Adverse Events
Day 0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Day 8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Day 28
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place