An interventional study of Supplement and Placebo in Metabolic Syndrome, sponsored by Jeffrey B. Schwimmer, MD. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Jeffrey B. Schwimmer, MD · Not applicable, Interventional, and Other
This study will determine changes in plasma C15:0 levels in young adults with BMI ≥ 25 in response to 12 weeks of daily oral C15:0 supplementation.
Metabolic syndrome is a disturbance in how the body processes both carbohydrates and fats. This condition has become common in children and young adults, especially in association with excess body fat. People with metabolic syndrome are at increased risk for type 2 diabetes, cardiovascular disease, and nonalcoholic fatty liver disease (NAFLD). Diet is believed to play an important role in both developing and treating metabolic syndrome. Studies have shown that low dietary intake of a type of fats known as odd chain fatty acids is associated with a higher risk for each of the metabolic syndrome associated conditions of diabetes, heart disease, and liver disease. Supplementation with one specific odd chain fatty acid known as C15:0 has shown to decrease the effects of metabolic syndrome in both cellular and animal models. In people, the epidemiology of consumption of C15:0 in the diet is consistent with this belief. However, clinical trials have yet to be done with supplemental C15:0. This study is a pilot study of C15:0 supplementation in a group of young adults at risk for metabolic syndrome. The study will determine how well supplementation with C15:0 daily for 12 weeks is able to raise levels of C15:0 in the blood when compared to placebo. The study will also look for signs that increasing blood levels of C15:0 leads to changes in physiology.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →This is the only study on the registry with Jeffrey B. Schwimmer, MD as lead sponsor.
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Exclusion Criteria:
200mg of pentadecanoic acid (C15:0) supplementation in capsules form
Dietary Supplement: Supplement
Matching placebo in capsules form
Other: Placebo
200mg C15:0 once daily
Matching placebo once daily
Change in plasma C15:0 levels
To determine changes in plasma C15:0 levels in response to daily supplementation of C15:
Time frame: Baseline to 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess safety and tolerability of C15:0 supplementation as measured by number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline to 12 weeks
Change in Weight
Change in Weight (kg)
Time frame: Baseline to 12 weeks
Change in BMI
Change in BMI (kg/m\^2)
Time frame: Baseline to 12 weeks
Change in serum alanine aminotransferase
Change in serum alanine aminotransferase (U/L)
Time frame: Baseline to 12 weeks
Change in serum aspartate aminotransferase
Change in serum aspartate aminotransferase (U/L)
Time frame: Baseline to 12 weeks
Change in serum glutamyl transpeptidase
Change in serum glutamyl transpeptidase (U/L)
Time frame: Baseline to 12 weeks
Change in serum total cholesterol
Change in serum total cholesterol (mg/dL)
Time frame: Baseline to 12 weeks
Change in serum LDL-cholesterol
Change in serum LDL-cholesterol (mg/dL)
Time frame: Baseline to 12 weeks
Change in serum HDL-cholesterol
Change in serum HDL-cholesterol (mg/dL)
Time frame: Baseline to 12 weeks
Change in High Sensitivity C-reactive protein
Change in High Sensitivity C-reactive protein (mg/L)
Time frame: Baseline to 12 weeks
Change in serum glucose
Change in serum glucose (mg/dL)
Time frame: Baseline to 12 weeks
Change in serum insulin
Change in serum insulin (μIU/mL)
Time frame: Baseline to 12 weeks
Change in hemoglobin
Change in hemoglobin (mg/dL)
Time frame: Baseline to 12 weeks
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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