N/A
Completed N=24
Bioavailability of SPMs in Obese Humans
Obesity Adult Onset
Source: ClinicalTrials.gov NCT04701138 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Mean Pro-inflammatory & Pro-resolving Metabolites — 15.6; 12.2; 6.6; 8.1 ng/mL
Summary
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.
* Aim 1a: To quantify plasma SPM concentrations in plasma (pg/mL), serum (pg/mL) and PBMCs before and after 4 weeks of supplementation with 'SPM Active.' The concentration of SPMs in plasma, in addition to other PUFA-derived metabolites that share the same enzymatic pathways as SPMs, will be established at baseline and post-intervention using mass spectrometry-based metabololipidomics.
* Aim 1b: To measure in vitro antibody responses of B cells in PBMC pool with in vitro stimulation and cytokine production before and after 4 weeks of supplementation with 'SPM Active.' In addition, researchers will quantify the relative abundance of differing immune cell populations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pro-inflammatory & Pro-resolving Metabolites |
15.6; 12.2; 6.6; 8.1; 8.0; 11.3 | — |
| SECONDARY Mean White Blood Cell Populations |
0.32; 0.33; 0.02; 0.03; 0.30; 0.30 | — |
Eligibility Criteria
Inclusion Criteria
- 24 (n=12 male + 12 female) obese (BMI 30-40 kg/m^2) subjects with age 50-65 years who are euglycemic and pre-diabetic (i.e. fasting glucose 70-125 mg/dL or HbA1c of 5.7-6.4%).
- Only post-menopausal females will be recruited in the female cohort to reduce the confounding effects of estrogen on lipid metabolism during supplementation.
Exclusion Criteria
- Those with fasting glucose values > 126 mg/dL or known type 2 diabetes
- Females who are pre-menopausal, pregnant, planning to become pregnant, breastfeeding or lactating
- Subjects consuming n-3 PUFA supplements in the last 3 months prior to enrollment, high consumption of fatty fish (>2 servings per week), and subjects with active autoimmune disease, liver disease, coagulopathy, hypothyroidism, known allergy to fish or shellfish, inability to give informed consent, or taking anticoagulants (e.g. warfarin and direct-acting anticoagulants), those taking estrogen or testosterone, and anyone taking daily aspirin, NSAIDs, or active asthma medications.
- Subjects receiving immunomodulatory or immunosuppressant therapy (corticosteroids or monoclonal antibodies) in the 4 weeks prior to study enrollment, and subjects with known active malignancy or undergoing treatment for malignancy will be excluded.
- Subjects who test positive for COVID-19 or have tested positive in the past will be excluded. Those who report COVID-19 or flu-like symptoms will be excluded, as well as those that fail to pass COVID-19 screening at baseline.
Data sourced from ClinicalTrials.gov (NCT04701138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.