This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status.
This study will investigate the effect of ENI Patented Whole Grape Extract versus placebo on antioxidant status. The primary objective is to determine antioxidant status by measuring total antioxidant capacity and superoxide dismutase (SOD) in blood and 8-OHdG and 8-isoprostane in first morning void urine samples prior to and after six weeks of supplementation with ENI Patented Whole Grape Extract. Secondary objectives will include the assessment of oxidized LDL (oxLDL) and safety evaluations: 1. oxLDL 2. Safety laboratory tests: CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT,bilirubin 3. Vital signs: heart rate and blood pressure 4. Adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
26
ENI Patented Whole Grape Extract
Placebo
KGK Synergize Inc.
London, Ontario, Canada
Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane
This study will investigate the effect of ENI Patented Whole Grape Extract versus placebo on antioxidant status. The primary objective is to determine antioxidant status by measuring total antioxidant capacity and superoxide dismutase (SOD) in blood and 8-OHdG and 8-isoprostane in first morning void urine samples prior to and after six weeks of supplementation with ENI Patented Whole Grape Extract.
Time frame: 6 weeks
Change from baseline in oxidized LDL (oxLDL).
Secondary objectives will include the assessment of oxidized LDL (oxLDL)
Time frame: 6 weeks
Change from baseline in safety lab test biomarkers including CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT, and bilirubin
This study will include the safety evaluations and measure if there are any abnormal levels of CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT,and bilirubin.
Time frame: 6 weeks
Change from baseline in vital signs: heart rate and blood pressure
This study will include measurement on change from baseline in vital signs: heart rate and blood pressure
Time frame: 6 weeks
Number of participants with adverse events
This study will also assess number of participants with adverse events during the entire intervention period.
Time frame: 6 weeks
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