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
  Purpose

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


Condition Intervention Phase
High Oxidation Stress
Oxidized LDL Level
Dietary Supplement: ENI Patented Whole Grape Extract
Other: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Ethical Naturals, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 26
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ENI Patented Whole Grape Extract
ENI Patented Whole Grape Extract (350 mg) per day
Dietary Supplement: ENI Patented Whole Grape Extract
ENI Patented Whole Grape Extract
Other Name: Whole Grape Extract
Placebo Comparator: Exicipient pill Other: Placebo
Placebo
Other Name: Other ingredients pill

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551706

Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
Ethical Naturals, Inc.
KGK Synergize Inc.
Investigators
Principal Investigator: Dale Wilson KGK Synergize Inc.
  More Information

No publications provided

Responsible Party: Ethical Naturals, Inc.
ClinicalTrials.gov Identifier: NCT01551706     History of Changes
Other Study ID Numbers: 11OAHE
Study First Received: February 21, 2012
Last Updated: July 3, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ethical Naturals, Inc.:
Total antioxidant capacity
SOD
8-OHdG
8-isoprostane
oxLDL

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 22, 2014