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

NCT ID: NCT01551706

Last Updated: 2012-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-06-30

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

Conditions

High Oxidation Stress; Oxidized LDL Level

Keywords

Total antioxidant capacity; SOD; 8-OHdG; 8-isoprostane; oxLDL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ENI Patented Whole Grape Extract

ENI Patented Whole Grape Extract (350 mg) per day

Group Type: ACTIVE_COMPARATOR

ENI Patented Whole Grape Extract

Intervention Type: DIETARY_SUPPLEMENT

ENI Patented Whole Grape Extract

Exicipient pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

ENI Patented Whole Grape Extract

ENI Patented Whole Grape Extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

Whole Grape Extract; Other ingredients pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Ethical Naturals, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dale Wilson

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

11OAHE

Identifier Type: -

Identifier Source: org_study_id