Trial Outcomes & Findings for Bioavailability of SPMs in Obese Humans (NCT NCT04701138)
NCT ID: NCT04701138
Last Updated: 2022-06-15
Results Overview
Mass spectrometry metabololipidomics analysis will be performed on plasma samples from pre/post supplementation blood draws to measure SPM concentrations. The study was powered to measure the following molecules of interest: 14-HDHA, 17-HDHA, and 18-HEPE.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
From Baseline (Week 1/Day1) through 28 to 30 days of supplementation
Results posted on
2022-06-15
Participant Flow
Participant milestones
| Measure |
Dietary Supplement
All subjects will receive the intervention (SPM Active Supplement)
SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability of SPMs in Obese Humans
Baseline characteristics by cohort
| Measure |
Dietary Supplement
n=23 Participants
All subjects will receive the intervention (SPM Active Supplement)
SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg.
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|---|---|
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Age, Continuous
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56 years
n=99 Participants
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Sex: Female, Male
Female
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13 Participants
n=99 Participants
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Sex: Female, Male
Male
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10 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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23 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=99 Participants
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Race (NIH/OMB)
White
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16 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=99 Participants
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Region of Enrollment
United States
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23 Participants
n=99 Participants
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Weight
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96.4 Kg
n=99 Participants
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Height
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170.2 cm
n=99 Participants
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Body Mass Index (BMI)
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33.1 Kg/m^2
n=99 Participants
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PRIMARY outcome
Timeframe: From Baseline (Week 1/Day1) through 28 to 30 days of supplementationMass spectrometry metabololipidomics analysis will be performed on plasma samples from pre/post supplementation blood draws to measure SPM concentrations. The study was powered to measure the following molecules of interest: 14-HDHA, 17-HDHA, and 18-HEPE.
Outcome measures
| Measure |
Dietary Supplement
n=23 Participants
All subjects will receive the intervention (SPM Active Supplement)
SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg.
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|---|---|
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Mean Pro-inflammatory & Pro-resolving Metabolites
Pre 14-HDHA
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15.6 ng/mL
Standard Deviation 11.5
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Mean Pro-inflammatory & Pro-resolving Metabolites
Post 14-HDHA
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12.2 ng/mL
Standard Deviation 5.4
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Mean Pro-inflammatory & Pro-resolving Metabolites
Pre 17-HDHA
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6.6 ng/mL
Standard Deviation 4.9
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Mean Pro-inflammatory & Pro-resolving Metabolites
Post 17-HDHA
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8.1 ng/mL
Standard Deviation 4.6
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Mean Pro-inflammatory & Pro-resolving Metabolites
Pre 18-HEPE
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8.0 ng/mL
Standard Deviation 6.2
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Mean Pro-inflammatory & Pro-resolving Metabolites
Post 18-HEPE
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11.3 ng/mL
Standard Deviation 10.3
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SECONDARY outcome
Timeframe: From Baseline (Week 1/Day1) through 28 to 30 days of supplementationImmunological phenotyping of blood peripheral mononuclear cells (PBMC) using flow cytometry will identify key immune cell populations pre/post supplementation. PBMC analyses represent B cell populations, monocyte populations, natural killer cell populations, and T cell populations. The relative abundance was calculated using two different flow cytometry panels with fluorescently labeled antibodies. The first panel measured the relative abundance of all B cell subsets, monocyte subsets, and NK cell subsets (i.e., all subsets within error add up to 1.0). The second panel measured the relative abundance of CD4 T cell subsets, CD8 T cell subsets, and NKT cells (i.e., all subsets within error add up to 1.0).
Outcome measures
| Measure |
Dietary Supplement
n=23 Participants
All subjects will receive the intervention (SPM Active Supplement)
SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg.
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|---|---|
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Mean White Blood Cell Populations
Pre CD4+ T Cells
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0.32 Relative abundance
Standard Deviation 0.07
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Mean White Blood Cell Populations
Post CD4+ T Cells
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0.33 Relative abundance
Standard Deviation 0.05
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Mean White Blood Cell Populations
Pre Activated CD4+ T Cells
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post Activated CD4+ T Cells
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0.03 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Pre Non-Activated CD4+ T Cells
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0.30 Relative abundance
Standard Deviation 0.07
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Mean White Blood Cell Populations
Post Non-Activated CD4+ T Cells
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0.30 Relative abundance
Standard Deviation 0.05
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Mean White Blood Cell Populations
Pre CD8 T Cells
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0.17 Relative abundance
Standard Deviation 0.07
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Mean White Blood Cell Populations
Post CD8 T Cells
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0.16 Relative abundance
Standard Deviation 0.05
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Mean White Blood Cell Populations
Pre Activated CD8 T Cells
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post Activated CD8 T Cells
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0.03 Relative abundance
Standard Deviation 0.02
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Mean White Blood Cell Populations
Pre Non-Activated CD8 T Cells
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0.15 Relative abundance
Standard Deviation 0.06
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Mean White Blood Cell Populations
Post Non-Activated CD8 T Cells
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0.13 Relative abundance
Standard Deviation 0.03
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Mean White Blood Cell Populations
Pre NKT Cells
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post NKT Cells
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Pre B Cells
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0.39 Relative abundance
Standard Deviation 0.08
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Mean White Blood Cell Populations
Post B Cells
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0.37 Relative abundance
Standard Deviation 0.11
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Mean White Blood Cell Populations
Pre Plasma Cells
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post Plasma Cells
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Pre Follicular B Cells
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0.01 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post Follicular B Cells
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0.01 Relative abundance
Standard Deviation 0.00
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Mean White Blood Cell Populations
Pre B Regs
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0.08 Relative abundance
Standard Deviation 0.04
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Mean White Blood Cell Populations
Post B Regs
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0.07 Relative abundance
Standard Deviation 0.04
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Mean White Blood Cell Populations
Pre Classical Monocytes
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0.06 Relative abundance
Standard Deviation 0.02
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Mean White Blood Cell Populations
Post Classical Monocytes
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0.06 Relative abundance
Standard Deviation 0.03
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Mean White Blood Cell Populations
Pre Intermediate Monocytes
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0.00 Relative abundance
Standard Deviation 0.00
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Mean White Blood Cell Populations
Post Intermediate Monocytes
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0.01 Relative abundance
Standard Deviation 0.00
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Mean White Blood Cell Populations
Pre Non-Classical Monocytes
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0.11 Relative abundance
Standard Deviation 0.06
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Mean White Blood Cell Populations
Post Non-Classical Monocytes
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0.10 Relative abundance
Standard Deviation 0.07
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Mean White Blood Cell Populations
Pre NK CD3-CD56HICD16-
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0.01 Relative abundance
Standard Deviation 0.00
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Mean White Blood Cell Populations
Post NK CD3-CD56HICD16-
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0.02 Relative abundance
Standard Deviation 0.03
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Mean White Blood Cell Populations
Pre NK CD3-CD56HICD16+
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0.01 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post NK CD3-CD56HICD16+
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Pre NK CD3-CD56dimCD16-
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0.23 Relative abundance
Standard Deviation 0.09
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Mean White Blood Cell Populations
Post NK CD3-CD56dimCD16-
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0.22 Relative abundance
Standard Deviation 0.08
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Mean White Blood Cell Populations
Pre NK CD3-CD56dimCD16+
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Post NK CD3-CD56dimCD16+
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0.02 Relative abundance
Standard Deviation 0.01
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Mean White Blood Cell Populations
Pre NK CD3-CD56-CD16+
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0.05 Relative abundance
Standard Deviation 0.03
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Mean White Blood Cell Populations
Post NK CD3-CD56-CD16+
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0.08 Relative abundance
Standard Deviation 0.08
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OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline (Week 1/Day1) through 28 to 30 days of supplementationPopulation: One participant's sample was removed from all B cell isolation and stimulation studies (ELISA data) due to PBMC cell death upon sample freezing.
B cells isolated from collected blood samples will be cultured in-vitro and stimulated with an antigen \& produced antibody concentrations will be measured via ELISA. This will be done for pre \& post blood samples.
Outcome measures
| Measure |
Dietary Supplement
n=22 Participants
All subjects will receive the intervention (SPM Active Supplement)
SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg.
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|---|---|
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Antibody Concentrations in Culture
Pre IgM
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465801.89 ng/mL
Standard Deviation 217732.43
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Antibody Concentrations in Culture
Post IgM
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457833.05 ng/mL
Standard Deviation 238874.79
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Antibody Concentrations in Culture
Pre IgG
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1024891.3 ng/mL
Standard Deviation 394612.17
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Antibody Concentrations in Culture
Post IgG
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789525.69 ng/mL
Standard Deviation 320595.08
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Adverse Events
Dietary Supplement
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
Saame Shaikh, PhD
University of North Carolina at Chapel Hill
Phone: 919-843-4348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place