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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
200mg C15:0 once daily
Matching placebo once daily
UC San Diego
La Jolla, California, United States
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
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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