High Oxidation Stress Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
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
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention