Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 6:48 PM
Study NCT ID:
NCT01551706
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2012-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
Sponsor:
Ethical Naturals, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: