An interventional study of SPM Active in Obesity Adult Onset, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science
Research Question: Does 4 weeks of supplementation with 'SPM Active' lead to a statistically significant increase in plasma SPM concentration for obese human subjects? Primary Aim 1: To compare plasma SPM concentrations and immunological fitness pre- and post- oral SPM administration in the obese.
Purpose: Specialized pro-resolving mediators (SPMs) are a superfamily of lipid metabolites, predominantly derived from the n-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic (EPA) and docosahexaenoic acids (DHA). Previous research has established that obese mice and humans have lower circulating levels of SPMs relative to lean controls. In this study, SPMs will be administered as a dietary supplement to obese human subjects to establish: 1) their bioavailability in plasma, serum and peripheral blood mononuclear cells (PBMCs) and 2) their effects on immune cell abundance and in vitro antibody production. The rationale for focusing on immune cells is that SPMs may be targeting their abundance and phenotype. This study does not intend to make any health or health-related claims.
Participants: A total of 24 (n=12 men + 12 women) obese (BMI 30-40 kg/m2) euglycemic and pre-diabetic subjects (fasting glucose 70-125 mg/dL or HbA1c of 5.7-6.4%) aged 50-65 years will be recruited by Dr. Erik Butler from the UNC Family Medicine Center in Chapel Hill.
Procedures (methods): This is a non-randomized uncontrolled clinical trial. The study will provide the intervention 'SPM Active' provided by Metagenics. All subjects will be advised to take 4 capsules per day (2 capsules with breakfast and 2 capsules with dinner) of 'SPM Active' for 4 weeks total. Each capsule contains 145 mg of SPMs for a total daily dose of 580 mg. Fasting blood will be drawn pre- and post-intervention using phlebotomy available under the direction of Dr. Butler. The scientific approach will rely on mass-spectrometry based metabololipidomics, immunophenotyping with flow cytometry, and anthropomorphic/blood pressure/BMI measurements (anthropometric measures are only intended for use in statistical analysis for confounding variables).
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
All subjects will receive the intervention (SPM Active Supplement)
Dietary 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.
Mean Pro-inflammatory & Pro-resolving Metabolites
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.
Time frame: From Baseline (Week 1/Day1) through 28 to 30 days of supplementation
Mean White Blood Cell Populations
Immunological 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).
Time frame: From Baseline (Week 1/Day1) through 28 to 30 days of supplementation
Antibody Concentrations in Culture
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.
Time frame: From Baseline (Week 1/Day1) through 28 to 30 days of supplementation
| Milestone | Dietary Supplement |
|---|---|
| Started | 24 |
| Completed | 23 |
| Not completed | 1 |
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.
| ng/mL | Dietary Supplement |
|---|---|
| Pre 14-HDHA | 15.6 ± 11.5 |
| Post 14-HDHA | 12.2 ± 5.4 |
| Pre 17-HDHA | 6.6 ± 4.9 |
| Post 17-HDHA | 8.1 ± 4.6 |
| Pre 18-HEPE | 8.0 ± 6.2 |
| Post 18-HEPE | 11.3 ± 10.3 |
Immunological 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).
| Relative abundance | Dietary Supplement |
|---|---|
| Pre CD4+ T Cells | 0.32 ± 0.07 |
| Post CD4+ T Cells | 0.33 ± 0.05 |
| Pre Activated CD4+ T Cells | 0.02 ± 0.01 |
| Post Activated CD4+ T Cells | 0.03 ± 0.01 |
| Pre Non-Activated CD4+ T Cells | 0.30 ± 0.07 |
| Post Non-Activated CD4+ T Cells | 0.30 ± 0.05 |
| Pre CD8 T Cells | 0.17 ± 0.07 |
| Post CD8 T Cells | 0.16 ± 0.05 |
| Pre Activated CD8 T Cells | 0.02 ± 0.01 |
| Post Activated CD8 T Cells | 0.03 ± 0.02 |
| Pre Non-Activated CD8 T Cells | 0.15 ± 0.06 |
| Post Non-Activated CD8 T Cells | 0.13 ± 0.03 |
| Pre NKT Cells | 0.02 ± 0.01 |
| Post NKT Cells | 0.02 ± 0.01 |
| Pre B Cells | 0.39 ± 0.08 |
| Post B Cells | 0.37 ± 0.11 |
| Pre Plasma Cells | 0.02 ± 0.01 |
| Post Plasma Cells | 0.02 ± 0.01 |
| Pre Follicular B Cells | 0.01 ± 0.01 |
| Post Follicular B Cells | 0.01 ± 0.00 |
| Pre B Regs | 0.08 ± 0.04 |
| Post B Regs | 0.07 ± 0.04 |
| Pre Classical Monocytes | 0.06 ± 0.02 |
| Post Classical Monocytes | 0.06 ± 0.03 |
| Pre Intermediate Monocytes | 0.00 ± 0.00 |
| Post Intermediate Monocytes | 0.01 ± 0.00 |
| Pre Non-Classical Monocytes | 0.11 ± 0.06 |
| Post Non-Classical Monocytes | 0.10 ± 0.07 |
| Pre NK CD3-CD56HICD16- | 0.01 ± 0.00 |
| Post NK CD3-CD56HICD16- | 0.02 ± 0.03 |
| Pre NK CD3-CD56HICD16+ | 0.01 ± 0.01 |
| Post NK CD3-CD56HICD16+ | 0.02 ± 0.01 |
| Pre NK CD3-CD56dimCD16- | 0.23 ± 0.09 |
| Post NK CD3-CD56dimCD16- | 0.22 ± 0.08 |
| Pre NK CD3-CD56dimCD16+ | 0.02 ± 0.01 |
| Post NK CD3-CD56dimCD16+ | 0.02 ± 0.01 |
| Pre NK CD3-CD56-CD16+ | 0.05 ± 0.03 |
| Post NK CD3-CD56-CD16+ | 0.08 ± 0.08 |
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.
| ng/mL | Dietary Supplement |
|---|---|
| Pre IgM | 465801.89 ± 217732.43 |
| Post IgM | 457833.05 ± 238874.79 |
| Pre IgG | 1024891.3 ± 394612.17 |
| Post IgG | 789525.69 ± 320595.08 |
Collected over From the time of signing informed consent through the last blood draw, ranging from 28 to 30 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dietary Supplement | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Dietary Supplement |
|---|---|
| Mean | 56 (52 to 61) |
| Sex: Female, Male(Participants) | Dietary Supplement |
|---|---|
| Female | 13 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Dietary Supplement |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Dietary Supplement |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Dietary Supplement |
|---|---|
| United States | 23 |
| Weight(Kg) | Dietary Supplement |
|---|---|
| Median | 96.4 (87.3 to 112.0) |
| Height(cm) | Dietary Supplement |
|---|---|
| Median | 170.2 (160.0 to 177.8) |
| Body Mass Index (BMI)(Kg/m^2) | Dietary Supplement |
|---|---|
| Median | 33.1 (31.0 to 36.0) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Each participant's deidentified metabololipidomics data and flow cytometry/immunophenotyping data will be shared via ImmPort
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill