Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans

NCT02213588 | Completed DMC

• 1 other identifier: ABG AOX-2 Efficacy
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Antioxidant

Outcome Measures

Primary Outcomes (1)

• Change in urine isoprostane

  Change from baseline in urinary antioxidant biomarker in 3 months.

  Baseline, 3 mo

Secondary Outcomes (5)

• Change in plasma isoprostane

  baseline, 3 mo

• Change in erythrocyte lysate superoxide dismutase

  baseline, 3.0 mo

• Change in plasma superoxide dismutase

  baseline, 3.0 mo

• Change in plasma catalase

  baseline, 3.0 mo

• Change in plasma 3-nitrotyrosine

  baseline, 3.0 mo

Study Arms (2)

AOX blend

ACTIVE COMPARATOR

Rosemary:Quercetin:Turmeric (300 mg total)

Dietary Supplement: AOX blend

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

AOX blend DIETARY_SUPPLEMENT

Antioxidant supplement

Also known as: Antioxidant blend

AOX blend

Placebo DIETARY_SUPPLEMENT

Also known as: Placebo sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Access Business Group: lead

Study Sites (1)

Southbay Pharma Research

Buena Park, California, 90620, United States

Location

Study Officials

• Richard Keech, M.D.

  Southbay Pharma Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (1)