HealthyNCT02213523
ABG Oxidative Stress Study Protocol-1
A study testing Plant concentrate A, Plant concentrate B and Plant concentrate C in people with Healthy, run by Access Business Group at 2 sites in United States.
Trial summary
This is a proof of concept study that evaluates the response to oxidative stress in healthy men after taking plant concentrates. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Plant concentrate A, Plant concentrate B and Plant concentrate C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Dec 2013
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult men between 45-65 yr old with low fruit and vegetable intake
- Individual with low fruit and vegetable intake and consuming fewer than 12 items found on the Recommended Foods Check (RFC) (AppendixI) per week. (score <12 pts)
- Individuals with screening blood and urine laboratory values within 20% of normal range indicated in the lab report (Appendix IV)
- Individual should be judged to be in good general health on the basis of an interview and abbreviated physical exam.
- Individual understands the procedures and agrees to participate in the study.
- Individual is willing to maintain their exercise habits and dietary pattern throughout the duration of the trial.
- Individual is willing to consume a diet or drink devoid of high content of quercetin (e.g. apple and onions), rosemary, turmeric, Holy basil, wasabi, broccoli seeds, and licorice thought the duration of the trial.
- Individual is able and willing to provide written informed consent and confidentiality agreement.
Who cannot join
- Use of dietary supplements within one week of DAy 1. Supplements include any vitamins, minerals, and herbal products, including herbal drink.
- Presence of, or clinical significant history of, cancer, cardiovascular, endocrine, kidney, liver, lung, gastrointestinal, metabolic disorder, absorption disorder such as Celiae or Crohn's disease and/or any other chronic health condition such as diabetes identified from the finding of the interview.
- Presence of cardiovascular disease and hypertension with inconsistent medication regimen, unstable conditions, and without proper physician's supervision identified from the findings fo the interview.
- Individual who use medicines 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)), and take any of these medications within 10 hours prior to the blood and urine sample collection.
- Individuals who eat spicy food (e.g. capsaicin from chili pepper) and drink coffee and tea 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.
Show all 9Show fewer
- History of 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 seeds, and licorice.
- Any condition that the principal Investigator believes amy put the subject under risk.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Quality of Life
Buena Park, California, 90620
Southbay Pharma Research
Buena Park, California, 90620
About this study
Official title: Proof of Concept Study to Evaluate the Effect of Oxidative Stress Response of Plant Concentrate Blends in Healthy Men
This is a proof of concept study that evaluates the response to oxidative stress in healthy men after taking plant concentrates.
Read the detailed description
Sustained oxidative stress may cause hypertension, insulin resistance, metabolic syndrome, cardiovascular disease and other chronic conditions. Diets rich in natural antioxidants is associated with protective effects on the investigators health. The strategy to prevent chronic disease development and in making up the nutritional gap in the investigators diet has shifted from vitamins and minerals supplementation to whole foods and whole food products.
The objectives is to evaluate the effect of oxidative stress response of plant concentrate blends. Also, we'll confirm that vitamins, minerals and plant concentrates will not influence the biomarker expression that were monitored in the oxidative stress biomarkers. Lastly, collecting additional information on whether blends of plant concentrate have other potential health benefits.
This study will test the dose-response of blends of plant concentrates. Healthy men (n=60) with low fruit and vegetable intake will participate in a 32 day or 46 days. Each treatment duration lasts 14 days. Microarray assay and real time-polymerase chain reaction will be performed.Genes associated with oxidative stress will me monitored. The outcome of this study will help us understand how to design and develop future antioxidant related products.
- Conditions
- Healthy
- Being tested
- Plant concentrate A, Plant concentrate B, Plant concentrate C, Plant concentrate D
- Keywords
- antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant concentrate ADietary supplement
Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
Plant concentrate BDietary supplement
Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
Plant concentrate CDietary supplement
Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
Plant concentrate DDietary supplement
Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
| Study group | Role | What they receive |
|---|---|---|
| Plant concentrate A | Experimental | Plant concentrate A containing Rosemary:Quercetin:Turmeric 5:3:1 Low dose (300 mg) to high dose (600 mg) Receives: Dietary Supplement: Plant concentrate A |
| Plant concentrate B | Experimental | Plant concentrate B containing Holy Basil: Wasabi: Broccoli 5:5:1 Low dose (300 mg) to high dose (600 mg) Receives: Dietary Supplement: Plant concentrate B |
| Plant concentrate C | Experimental | Plant concentrate C containing Holy Basil:Rosemary:Broccoli seed:Turmeric 2:2:1:1 Low dose (300 mg) to High dose (600 mg) Receives: Dietary Supplement: Plant concentrate C |
| Plant concentrate D | Experimental | Plant concentrate D containing Rosemary:Licorice:Turmeric 1:1:1 Low dose (300 mg) to High dose (600 mg) Receives: Dietary Supplement: Plant concentrate D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine 8-isoprostane
Change in antioxidant biomarker from baseline to day 15
Measured: Day 1, 15
Secondary outcomes (4)
Change in erythrocyte Superoxide Dismutase
Change in antioxidant biomarker from baseline to day 15
Measured: 1, 15
Change in plasma malondialdehyde
Change in antioxidant biomarker from baseline to day 15
Measured: Day 1, 15
Plasma hemoxygenase-1
Change in antioxidant biomarker from baseline to day 15
Measured: Day 1, 15
Erythrocyte glutathione peroxidase
Change in antioxidant biomarker from baseline to day 15
Measured: Day 1, 15
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 startSep 2012
- Primary completionNov 2012
- Study completionDec 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT02213523
- Sponsor's protocol ID
- ABG AOX-1
- 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
- Proof of Concept Study to Evaluate the Effect of Oxidative Stress Response of Plant Concentrate Blends in Healthy Men
- ClinicalTrials.gov ID
- NCT02213523
- Acronym / sponsor ID
- ABG AOX-1
- Conditions
- Healthy
- Keywords
- antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2013 (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 is a proof of concept study that evaluates the response to oxidative stress in healthy men after taking plant concentrates.
Detailed description
Sustained oxidative stress may cause hypertension, insulin resistance, metabolic syndrome, cardiovascular disease and other chronic conditions. Diets rich in natural antioxidants is associated with protective effects on the investigators health. The strategy to prevent chronic disease development and in making up the nutritional gap in the investigators diet has shifted from vitamins and minerals supplementation to whole foods and whole food products.
The objectives is to evaluate the effect of oxidative stress response of plant concentrate blends. Also, we'll confirm that vitamins, minerals and plant concentrates will not influence the biomarker expression that were monitored in the oxidative stress biomarkers. Lastly, collecting additional information on whether blends of plant concentrate have other potential health benefits.
This study will test the dose-response of blends of plant concentrates. Healthy men (n=60) with low fruit and vegetable intake will participate in a 32 day or 46 days. Each treatment duration lasts 14 days. Microarray assay and real time-polymerase chain reaction will be performed.Genes associated with oxidative stress will me monitored. The outcome of this study will help us understand how to design and develop future antioxidant related products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plant concentrate A | Experimental | Dietary Supplement: Plant concentrate APlant concentrate A containing Rosemary:Quercetin:Turmeric 5:3:1 Low dose (300 mg) to high dose (600 mg) |
| Plant concentrate B | Experimental | Dietary Supplement: Plant concentrate BPlant concentrate B containing Holy Basil: Wasabi: Broccoli 5:5:1 Low dose (300 mg) to high dose (600 mg) |
| Plant concentrate C | Experimental | Dietary Supplement: Plant concentrate CPlant concentrate C containing Holy Basil:Rosemary:Broccoli seed:Turmeric 2:2:1:1 Low dose (300 mg) to High dose (600 mg) |
| Plant concentrate D | Experimental | Dietary Supplement: Plant concentrate DPlant concentrate D containing Rosemary:Licorice:Turmeric 1:1:1 Low dose (300 mg) to High dose (600 mg) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adult men between 45-65 yr old with low fruit and vegetable intake
- Individual with low fruit and vegetable intake and consuming fewer than 12 items found on the Recommended Foods Check (RFC) (AppendixI) per week. (score <12 pts)
- Individuals with screening blood and urine laboratory values within 20% of normal range indicated in the lab report (Appendix IV)
- Individual should be judged to be in good general health on the basis of an interview and abbreviated physical exam.
- Individual understands the procedures and agrees to participate in the study.
Key exclusion criteria (9 listed)
- Use of dietary supplements within one week of DAy 1. Supplements include any vitamins, minerals, and herbal products, including herbal drink.
- Presence of, or clinical significant history of, cancer, cardiovascular, endocrine, kidney, liver, lung, gastrointestinal, metabolic disorder, absorption disorder such as Celiae or Crohn's disease and/or any other chronic health condition such as diabetes identified from the finding of the interview.
- Presence of cardiovascular disease and hypertension with inconsistent medication regimen, unstable conditions, and without proper physician's supervision identified from the findings fo the interview.
- Individual who use medicines 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)), and take any of these medications within 10 hours prior to the blood and urine sample collection.
- Individuals who eat spicy food (e.g. capsaicin from chili pepper) and drink coffee and tea including herbal teas within 10 hours prior to the blood and urine sample collection.
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 |
|---|---|---|
| Plant concentrate AScreening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week. | Dietary supplement | Plant concentrate A |
| Plant concentrate BScreening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week. | Dietary supplement | Plant concentrate B |
| Plant concentrate CScreening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week. | Dietary supplement | Plant concentrate C |
| Plant concentrate DScreening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week. | Dietary supplement | Plant concentrate D |
Primary outcome
Change in urine 8-isoprostane
Time frame: Day 1, 15
Change in antioxidant biomarker from baseline to day 15
4 secondary outcomes
Change in erythrocyte Superoxide Dismutase
Time frame: 1, 15
Change in plasma malondialdehyde
Time frame: Day 1, 15
Plasma hemoxygenase-1
Time frame: Day 1, 15
Erythrocyte glutathione peroxidase
Time frame: Day 1, 15
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant concentrate A, Plant concentrate B and Plant concentrate C in people with Healthy, run by Access Business Group at 2 sites 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 8 inclusion and 9 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 2 sites 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. 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 8-isoprostane (time frame: Day 1, 15). 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.