High Oxidation StressPhase 1NCT01551706
Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
A Phase 1 study testing ENI Patented Whole Grape Extract in people with High Oxidation Stress and Oxidized LDL Level, run by Ethical Naturals, Inc. at 1 site in Canada.
Trial summary
This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Oxidation Stress, Oxidized LDL Level
- What is being tested?
- ENI Patented Whole Grape Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Allergy or sensitivity to test product ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- oxLDL
- Safety laboratory tests: CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT,bilirubin
- Vital signs: heart rate and blood pressure
- Adverse events
- Conditions
- High Oxidation Stress, Oxidized LDL Level
- Being tested
- ENI Patented Whole Grape Extract, Placebo
- Keywords
- Total antioxidant capacity, SOD, 8-OHdG, 8-isoprostane, oxLDL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENI Patented Whole Grape ExtractDietary supplement
Also called Whole Grape Extract
ENI Patented Whole Grape Extract
PlaceboOther
Also called Other ingredients pill
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ENI Patented Whole Grape Extract | Active comparator | ENI Patented Whole Grape Extract (350 mg) per day Receives: Dietary Supplement: ENI Patented Whole Grape Extract |
| Exicipient pill | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
Change from baseline in oxidized LDL (oxLDL).
Secondary objectives will include the assessment of oxidized LDL (oxLDL)
Measured: 6 weeks
Change from baseline in safety lab test biomarkers including CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT, and bilirubin
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.
Measured: 6 weeks
Change from baseline in vital signs: heart rate and blood pressure
This study will include measurement on change from baseline in vital signs: heart rate and blood pressure
Measured: 6 weeks
Number of participants with adverse events
This study will also assess number of participants with adverse events during the entire intervention period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Oxidation StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethical Naturals, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551706
- Sponsor's protocol ID
- 11OAHE
- Status last verified
- Jul 2012
- First submitted
- 21 Feb 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
- ClinicalTrials.gov ID
- NCT01551706
- Acronym / sponsor ID
- 11OAHE
- Conditions
- High Oxidation Stress, Oxidized LDL Level
- Keywords
- Total antioxidant capacity, SOD, 8-OHdG, 8-isoprostane, oxLDL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ethical Naturals, Inc.University, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- oxLDL
- Safety laboratory tests: CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT,bilirubin
- Vital signs: heart rate and blood pressure
- Adverse events
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENI Patented Whole Grape Extract | Active comparator | Dietary Supplement: ENI Patented Whole Grape ExtractENI Patented Whole Grape Extract (350 mg) per day |
| Exicipient pill | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- One or more of the following conditions:
- Subjects who are smokers agree to report smoking habits at each visit and do not plan on changing their smoking habits during the study.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENI Patented Whole Grape ExtractAlso: Whole Grape ExtractENI Patented Whole Grape Extract | Dietary supplement | ENI Patented Whole Grape Extract |
| PlaceboAlso: Other ingredients pillPlacebo | Other | Exicipient pill |
Primary outcome
Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane
Time frame: 6 weeks
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.
4 secondary outcomes
Change from baseline in oxidized LDL (oxLDL).
Time frame: 6 weeks
Change from baseline in safety lab test biomarkers including CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT, and bilirubin
Time frame: 6 weeks
Change from baseline in vital signs: heart rate and blood pressure
Time frame: 6 weeks
Number of participants with adverse events
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Wilson principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENI Patented Whole Grape Extract in people with High Oxidation Stress and Oxidized LDL Level, run by Ethical Naturals, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012; AzTrials last refreshed its copy on 6 Nov 2026.