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Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans

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ClinicalTrials.gov Identifier: NCT02213588
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Access Business Group

Brief Summary:
This study evaluates the response to oxidative stress in healthy men and women after taking a blend of plant concentrate.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: AOX blend Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Active Comparator: AOX blend
Rosemary:Quercetin:Turmeric (300 mg total)
Dietary Supplement: AOX blend
Antioxidant supplement
Other Name: Antioxidant blend

Placebo Comparator: Placebo
Maltodextrin
Dietary Supplement: Placebo
Other Name: Placebo sugar pill




Primary Outcome Measures :
  1. Change in urine isoprostane [ Time Frame: Baseline, 3 mo ]
    Change from baseline in urinary antioxidant biomarker in 3 months.


Secondary Outcome Measures :
  1. Change in plasma isoprostane [ Time Frame: baseline, 3 mo ]
    Change in baseline blood antioxidant marker from baseline to 3 month

  2. Change in erythrocyte lysate superoxide dismutase [ Time Frame: baseline, 3.0 mo ]
    Change in antioxidant biomarker from baseline to 3 months

  3. Change in plasma superoxide dismutase [ Time Frame: baseline, 3.0 mo ]
    Change in antioxidant biomarker from baseline to 3 months

  4. Change in plasma catalase [ Time Frame: baseline, 3.0 mo ]
    Change in antioxidant biomarker from baseline to 3 months

  5. Change in plasma 3-nitrotyrosine [ Time Frame: baseline, 3.0 mo ]
    Change in antioxidant biomarker from baseline to 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult men and women between 18 - 65 yr with low fruit and vegetable intake.
  2. 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
  3. 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.
  4. 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.
  5. 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.
  6. Individual understands the procedures and agrees to participate in the study.
  7. 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.
  8. 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.
  9. Individual is able and willing to provide written informed consent and confidentiality agreement.

Exclusion Criteria:

  • Persons will be excused from participating in the study if any of the following conditions exist:

    1. Use of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks.
    2. 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.
    3. Presence of gallstones or history of gallbladder disease.
    4. Presence or history of diabetes.
    5. 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.
    6. 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.
    7. Participation in another clinical trial within 30 days of enrollment into the study.
    8. History or current abuse of nicotine, drugs or alcohol, or intake > 3 alcoholic beverages per day
    9. Have known allergy to the ingredients in the tested samples such as quercetin, rosemary, turmeric, Holy basil, wasabi, broccoli seed, and licorice.
    10. Any condition that the Principal Investigator believes may put the subject at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213588


Locations
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United States, California
Southbay Pharma Research
Buena Park, California, United States, 90620
Sponsors and Collaborators
Access Business Group
Investigators
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Principal Investigator: Richard Keech, M.D. Southbay Pharma Research

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Responsible Party: Access Business Group
ClinicalTrials.gov Identifier: NCT02213588     History of Changes
Other Study ID Numbers: ABG AOX-2 Efficacy
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Keywords provided by Access Business Group:
Antioxidant

Additional relevant MeSH terms:
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Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs