HealthyNCT02213588
Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans
A study testing AOX blend in people with Healthy, run by Access Business Group at 1 site in United States.
Trial summary
This study evaluates the response to oxidative stress in healthy men and women after taking a blend of plant concentrate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AOX blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2014
- Phase
- Interventional
- 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
- Healthy adult men and women between 18 - 65 yr with low fruit and vegetable intake.
- Individual with low fruit and vegetable intake and consuming fewer than 12 items found on the Recommended Foods Checklist (RFC) (APPENDIX I) per week. (score < 12 points
- Safety data: Blood chemistry results specifically Blood Urea Nitrogen (BUN), Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-glutamyl transpeptidase (GGTP), Total Bilirubin and alkaline phosphatase and urinalysis results, specifically urine pH, protein, glucose, ketone and bilirubin levels within +/- 20% of normal value indicated in the lab report.
- Subjects with laboratory test results exceeding by >20% of the upper limit of the reference range in Creatine Phosphokinase, uric acid or blood glucose may be included in the study if the Principal Investigator decides those subjects are sufficiently healthy to participate safely in the study.
- Individual should be judged to be in good general health on the basis of an interview and a physician will perform an abbreviated physical exam.
- Individual understands the procedures and agrees to participate in the study.
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- Individual is willing to maintain their exercise habits and dietary pattern throughout the duration of the trial except as instructed to avoid high content of quercetin (for example, quercetin can be found in apple and onion), rosemary, turmeric throughout the duration of the trial.
- Individual is willing to consume a diet or drinks devoid with high content of quercetin (for example, quercetin can be found in apple and onion), rosemary, turmeric throughout the duration of the trial.
- Individual is able and willing to provide written informed consent and confidentiality agreement.
Who cannot join
- Persons will be excused from participating in the study if any of the following conditions exist:
- Use of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks.
- Presence of, or clinical significant history of, cancer, cardiovascular, endocrine, kidney, liver, lung, gastrointestinal, metabolic disorder, absorption disorder such as Celiac or Crohn's disease and/or any other chronic health condition such as diabetes identified from the findings of the interview.
- Presence of gallstones or history of gallbladder disease.
- Presence or history of diabetes.
- Presence of cardiovascular disease and hypertension with inconsistent medication regimen, unstable conditions, and without proper physician's supervision identified from the findings of the interview.
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- Ten hours prior to the blood and urine sample collection, subjects should refrain from using medications such as statins (e.g., simvastatin, fluvastatin), NSAIDS including aspirin, nitric oxide (eNOS) activators or inhibitors (e.g., selegiline, Viagra), and angiotensin II receptor blocker (e.g., Telmisartan (blood pressure)), take any of these medications Participant who eats spicy food (e.g., capsaicin from chili pepper) and/or drinks coffee and teas including herbal teas within 10 hours prior to the blood and urine sample collection.
- Participation in another clinical trial within 30 days of enrollment into the study.
- History or current abuse of nicotine, drugs or alcohol, or intake > 3 alcoholic beverages per day
- Have known allergy to the ingredients in the tested samples such as quercetin, rosemary, turmeric, Holy basil, wasabi, broccoli seed, and licorice.
- Any condition that the Principal Investigator believes may put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southbay Pharma Research
Buena Park, California, 90620
About this study
This study evaluates the response to oxidative stress in healthy men and women after taking a blend of plant concentrate.
Read the detailed description
The purpose of this study is to evaluate how blends of plant concentrates impacts oxidative stress in humans. Biomarkers of oxidative stress will be measured at three time points in 3 month intervention. Based on our proof of concept dose response study, it was shown that the plant concentrate at the proposed dose can lower markers of oxidative damage and induce the production of antioxidant enzymes. We would like to confirm these findings and further evaluate the implication of increased antioxidative enzymes as seeing in our proof of concept study. An acute oxidative stress will be induced by a high glycemic drink and short aerobic exercise and the response during the induction of an acute oxidative stress as well as the recovery from an acute oxidative stress. Since the induction of antioxidative enzymes not only is linked to the protection of proteins and lipids from oxidative damage, it is also linked to the protection of DNA damage. Therefore, in this study, comet assay will be performed to evaluate the integrity of DNA.
- Conditions
- Healthy
- Being tested
- AOX blend, Placebo
- Keywords
- Antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOX blendDietary supplement
Also called Antioxidant blend
Antioxidant supplement
PlaceboDietary supplement
Also called Placebo sugar pill
| Study group | Role | What they receive |
|---|---|---|
| AOX blend | Active comparator | Rosemary:Quercetin:Turmeric (300 mg total) Receives: Dietary Supplement: AOX blend |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine isoprostane
Change from baseline in urinary antioxidant biomarker in 3 months.
Measured: Baseline, 3 mo
Secondary outcomes (5)
Change in plasma isoprostane
Change in baseline blood antioxidant marker from baseline to 3 month
Measured: baseline, 3 mo
Change in erythrocyte lysate superoxide dismutase
Change in antioxidant biomarker from baseline to 3 months
Measured: baseline, 3.0 mo
Change in plasma superoxide dismutase
Change in antioxidant biomarker from baseline to 3 months
Measured: baseline, 3.0 mo
Change in plasma catalase
Change in antioxidant biomarker from baseline to 3 months
Measured: baseline, 3.0 mo
Change in plasma 3-nitrotyrosine
Change in antioxidant biomarker from baseline to 3 months
Measured: baseline, 3.0 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Keech, M.D., Principal investigator, Southbay Pharma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213588
- Sponsor's protocol ID
- ABG AOX-2 Efficacy
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans
- ClinicalTrials.gov ID
- NCT02213588
- Acronym / sponsor ID
- ABG AOX-2 Efficacy
- Conditions
- Healthy
- Keywords
- Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Aug 2014 (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 study evaluates the response to oxidative stress in healthy men and women after taking a blend of plant concentrate.
Detailed description
The purpose of this study is to evaluate how blends of plant concentrates impacts oxidative stress in humans. Biomarkers of oxidative stress will be measured at three time points in 3 month intervention. Based on our proof of concept dose response study, it was shown that the plant concentrate at the proposed dose can lower markers of oxidative damage and induce the production of antioxidant enzymes. We would like to confirm these findings and further evaluate the implication of increased antioxidative enzymes as seeing in our proof of concept study. An acute oxidative stress will be induced by a high glycemic drink and short aerobic exercise and the response during the induction of an acute oxidative stress as well as the recovery from an acute oxidative stress. Since the induction of antioxidative enzymes not only is linked to the protection of proteins and lipids from oxidative damage, it is also linked to the protection of DNA damage. Therefore, in this study, comet assay will be performed to evaluate the integrity of DNA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOX blend | Active comparator | Dietary Supplement: AOX blendRosemary:Quercetin:Turmeric (300 mg total) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adult men and women between 18 - 65 yr with low fruit and vegetable intake.
- Individual with low fruit and vegetable intake and consuming fewer than 12 items found on the Recommended Foods Checklist (RFC) (APPENDIX I) per week. (score < 12 points
- Safety data: Blood chemistry results specifically Blood Urea Nitrogen (BUN), Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-glutamyl transpeptidase (GGTP), Total Bilirubin and alkaline phosphatase and urinalysis results, specifically urine pH, protein, glucose, ketone and bilirubin levels within +/- 20% of normal value indicated in the lab report.
- Subjects with laboratory test results exceeding by >20% of the upper limit of the reference range in Creatine Phosphokinase, uric acid or blood glucose may be included in the study if the Principal Investigator decides those subjects are sufficiently healthy to participate safely in the study.
- Individual should be judged to be in good general health on the basis of an interview and a physician will perform an abbreviated physical exam.
Key exclusion criteria (11 listed)
- Persons will be excused from participating in the study if any of the following conditions exist:
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 |
|---|---|---|
| AOX blendAlso: Antioxidant blendAntioxidant supplement | Dietary supplement | AOX blend |
| PlaceboAlso: Placebo sugar pill | Dietary supplement | Placebo |
Primary outcome
Change in urine isoprostane
Time frame: Baseline, 3 mo
Change from baseline in urinary antioxidant biomarker in 3 months.
5 secondary outcomes
Change in plasma isoprostane
Time frame: baseline, 3 mo
Change in erythrocyte lysate superoxide dismutase
Time frame: baseline, 3.0 mo
Change in plasma superoxide dismutase
Time frame: baseline, 3.0 mo
Change in plasma catalase
Time frame: baseline, 3.0 mo
Change in plasma 3-nitrotyrosine
Time frame: baseline, 3.0 mo
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 11 Aug 2014.
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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.
Richard Keech, M.D. principal investigator
Southbay Pharma Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOX blend in people with Healthy, run by Access Business Group at 1 site in United States.
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 9 inclusion and 11 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 11 Aug 2014. 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 United States. 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.
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 in urine isoprostane (time frame: Baseline, 3 mo). 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 11 Aug 2014.