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

NCT01551706 | Completed Phase 1 DMC

• 1 other identifier: 11OAHE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

High Oxidation Stress; Oxidized LDL Level

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane

  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.

  6 weeks

Secondary Outcomes (4)

• Change from baseline in oxidized LDL (oxLDL).

  6 weeks

• Change from baseline in safety lab test biomarkers including CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT, and bilirubin

  6 weeks

• Change from baseline in vital signs: heart rate and blood pressure

  6 weeks

• Number of participants with adverse events

  6 weeks

Study Arms (2)

ENI Patented Whole Grape Extract

ACTIVE COMPARATOR

ENI Patented Whole Grape Extract (350 mg) per day

Dietary Supplement: ENI Patented Whole Grape Extract

Exicipient pill

PLACEBO COMPARATOR

Other: Placebo

Interventions

ENI Patented Whole Grape Extract DIETARY_SUPPLEMENT

ENI Patented Whole Grape Extract

Also known as: Whole Grape Extract

ENI Patented Whole Grape Extract

Placebo OTHER

Placebo

Also known as: Other ingredients pill

Exicipient pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 - 65 years of age
• 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
• 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
• Subjects who are smokers agree to report smoking habits at each visit and do not plan on changing their smoking habits during the study.
• Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• 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
• Use of medication for the treatment of hypertension
• Use of medication for vasodilation, including nitric oxide releasing patches
• Use of medication for erectile dysfunction
• Use of medication (prescribed or over the counter) for weight loss
• Use of statins, fibrates, niacin, or any other medication for the treatment of hypercholesterolemia
• Use of anticoagulants
• 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)
• 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.
• Participation in a clinical research trial within 30 days prior to baseline
• 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

Sponsors & Collaborators

• Ethical Naturals, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Interventions

whole grape extract

Study Officials

• Dale Wilson

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 13, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

CA (1)