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

This study has been completed.
Sponsor:
Collaborator:
KGK Synergize Inc.
Information provided by (Responsible Party):
Ethical Naturals, Inc.
ClinicalTrials.gov Identifier:
NCT01551706
First received: February 21, 2012
Last updated: July 3, 2012
Last verified: July 2012

February 21, 2012
July 3, 2012
February 2012
April 2012   (final data collection date for primary outcome measure)
Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
This study will investigate the effect of ORAC-15M™ 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 ORAC-15M™ Grape Extract.
Complete list of historical versions of study NCT01551706 on ClinicalTrials.gov Archive Site
  • Change from baseline in oxidized LDL (oxLDL). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Secondary objectives will include the assessment of oxidized LDL (oxLDL)
  • Change from baseline in safety lab test biomarkers including CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT, and bilirubin [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Change from baseline in vital signs: heart rate and blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    This study will include measurement on change from baseline in vital signs: heart rate and blood pressure
  • Number of participants with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    This study will also assess number of participants with adverse events during the entire intervention period.
Same as current
Not Provided
Not Provided
 
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

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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • High Oxidation Stress
  • Oxidized LDL Level
  • Dietary Supplement: ENI Patented Whole Grape Extract
    ENI Patented Whole Grape Extract
    Other Name: Whole Grape Extract
  • Other: Placebo
    Placebo
    Other Name: Other ingredients pill
  • Active Comparator: ENI Patented Whole Grape Extract
    ENI Patented Whole Grape Extract (350 mg) per day
    Intervention: Dietary Supplement: ENI Patented Whole Grape Extract
  • Placebo Comparator: Exicipient pill
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female 18 - 65 years of age
  2. If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

    OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

    • Double-barrier method (condoms with spermicide or diaphragm with spermicide)
    • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Intrauterine devices
    • Vasectomy of partner (shown successful as per appropriate follow-up)
    • Abstinence
  3. One or more of the following conditions:

    • Pre-hypertension defined as diastolic blood pressure of 80-89 mmHg and systolic blood pressure of 139 or lower at screening
    • BMI from 25.0 to 34.9 kg/m2
    • Pre-diabetes defined as a fasting plasma glucose from 5.2 to 6.9 mmol/L
  4. Subjects who are smokers agree to report smoking habits at each visit and do not plan on changing their smoking habits during the study.
  5. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  2. Subject has any clinically significant medical conditions including cardiovascular disease,hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90mmHg), diabetes, liver or kidney disease
  3. Use of medication for the treatment of hypertension
  4. Use of medication for vasodilation, including nitric oxide releasing patches
  5. Use of medication for erectile dysfunction
  6. Use of medication (prescribed or over the counter) for weight loss
  7. Use of statins, fibrates, niacin, or any other medication for the treatment of hypercholesterolemia
  8. Use of anticoagulants
  9. Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
  10. Use of natural health products (NHPs)/dietary supplements that are known to have significant antioxidant activity within 2 weeks prior to baseline and during the course of the study including but not limited to vitamins A, C, and E, selenium and zinc.
  11. Participation in a clinical research trial within 30 days prior to baseline
  12. Clinically significant abnormal laboratory results at screening including

    • AST, ALT and/or bilirubin > 2 x the ULN
    • Serum creatinine >1.5 x the ULN or eGFR < 60
    • hemoglobin < 140 g/L for males and < 123 g/L for females
  13. Allergy or sensitivity to test product ingredients
  14. Individuals who are cognitively impaired and/or who are unable to give informed consent
  15. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01551706
11OAHE
Yes
Ethical Naturals, Inc.
Ethical Naturals, Inc.
KGK Synergize Inc.
Principal Investigator: Dale Wilson KGK Synergize Inc.
Ethical Naturals, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP