Other Endocrine/Nutritional/Metabolic Disorder Clinical Trial
Official title:
An Open-Label Single-Center Study to Determine Safety and Effects of Novel Nutritional Blend on Inflammatory Balance Markers and Metabolic Parameters
This open label study seeks to study the effects of a nutritional supplement on inflammatory markers, metabolic parameters, and safety in subjects compared to baseline after taking supplement for 2 and 4 months.
Primary endpoint will be to determine if nutritional supplement decreases the metabolic
parameter of triglycerides. Numerous studies have demonstrated the efficacy of fish oil on
reducing triglycerides in subjects taking fish oil at similar doses provided in our product
(see references).
Additional metabolic parameters will be measured as secondary endpoints, including abdominal
obesity, HDL cholesterol, blood pressure, fasting glucose, haemoglobin A1c, skin glycation
(AGEs), pulse wave velocity, skin carotenoids, serum 25(OH)D concentrations, weight, and LDL
density, particle size and number. The novel nutritional supplement contains many nutrients
that have been shown to improve metabolic parameters.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label