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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
41
It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner.
Texas Diabetes & Endocrinology
Austin, Texas, United States
Utah State University
Logan, Utah, United States
Change from Baseline in Serum Triglycerides at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Abdominal Obesity at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in HDL cholesterol at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Fasting glucose at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Total cholesterol at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in LDL density, particle size, and number at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Hemoglobin A1c at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Skin glycation (AGEs) at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Pulse wave velocity measurements at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Erythrocyte sedimentation rate at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
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Change from Baseline in Cytokine and additional markers at 2 months and 4 months
TNF-α, TNF Receptors 60 and 80, IL-1β, IL-6, IL-1, IL-2, ICAM-1, hsCRP, IL-10, sVCAM-1, insulin, leptin, and adiponectin
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Serum 25(OH)D concentrations at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Skin carotenoids at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Weight at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Red blood cell fatty acid profile at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Chemistry panel at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Thyroid panel at 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change from Baseline in Vital signs at 2 months and 4 months
Heart Rate and Blood Pressure
Time frame: Baseline, 2 months, 4 months