NCT01551706

Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status

A Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ethical Naturals, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status.

Detailed description

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

Conditions

• High Oxidation Stress
• Oxidized LDL Level

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ENI Patented Whole Grape Extract	ENI Patented Whole Grape Extract
OTHER	Placebo	Placebo

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2012-03-13
• Last updated: 2012-07-04

Locations

1 site across 1 country: Canada