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ABG Oxidative Stress Study Protocol-1

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ClinicalTrials.gov Identifier: NCT02213523
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Access Business Group

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date August 11, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Change in urine 8-isoprostane [ Time Frame: Day 1, 15 ]
Change in antioxidant biomarker from baseline to day 15
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • Change in erythrocyte Superoxide Dismutase [ Time Frame: 1, 15 ]
    Change in antioxidant biomarker from baseline to day 15
  • Change in plasma malondialdehyde [ Time Frame: Day 1, 15 ]
    Change in antioxidant biomarker from baseline to day 15
  • Plasma hemoxygenase-1 [ Time Frame: Day 1, 15 ]
    Change in antioxidant biomarker from baseline to day 15
  • Erythrocyte glutathione peroxidase [ Time Frame: Day 1, 15 ]
    Change in antioxidant biomarker from baseline to day 15
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABG Oxidative Stress Study Protocol-1
Official Title  ICMJE Proof of Concept Study to Evaluate the Effect of Oxidative Stress Response of Plant Concentrate Blends in Healthy Men
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Plant concentrate A
    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.
  • Dietary Supplement: Plant concentrate B
    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.
  • Dietary Supplement: Plant concentrate C
    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.
  • Dietary Supplement: Plant concentrate D
    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 Arms  ICMJE
  • Experimental: Plant concentrate A
    Plant concentrate A containing Rosemary:Quercetin:Turmeric 5:3:1 Low dose (300 mg) to high dose (600 mg)
    Intervention: Dietary Supplement: Plant concentrate A
  • Experimental: Plant concentrate B
    Plant concentrate B containing Holy Basil: Wasabi: Broccoli 5:5:1 Low dose (300 mg) to high dose (600 mg)
    Intervention: Dietary Supplement: Plant concentrate B
  • Experimental: Plant concentrate C
    Plant concentrate C containing Holy Basil:Rosemary:Broccoli seed:Turmeric 2:2:1:1 Low dose (300 mg) to High dose (600 mg)
    Intervention: Dietary Supplement: Plant concentrate C
  • Experimental: Plant concentrate D
    Plant concentrate D containing Rosemary:Licorice:Turmeric 1:1:1 Low dose (300 mg) to High dose (600 mg)
    Intervention: Dietary Supplement: Plant concentrate D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2014)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213523
Other Study ID Numbers  ICMJE ABG AOX-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Access Business Group
Study Sponsor  ICMJE Access Business Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Keech, M.D. Southbay Pharma Research
PRS Account Access Business Group
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP