Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: AOX blend; Dietary Supplement: Placebo

• Registration Number: NCT02213588
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-07
• Primary Completion: 2013-12
• Status Verified: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Last Update Submitted: 2014-08-07
• Study First Posted: 2014-08-11
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOX blend	AOX blend	Rosemary:Quercetin:Turmeric (300 mg total)
Placebo	Placebo	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Change in urine isoprostane	Baseline, 3 mo	Change from baseline in urinary antioxidant biomarker in 3 months.

Secondary Outcome Measures

Name	Time	Method
Change in erythrocyte lysate superoxide dismutase	baseline, 3.0 mo	Change in antioxidant biomarker from baseline to 3 months
Change in plasma superoxide dismutase	baseline, 3.0 mo	Change in antioxidant biomarker from baseline to 3 months
Change in plasma isoprostane	baseline, 3 mo	Change in baseline blood antioxidant marker from baseline to 3 month
Change in plasma 3-nitrotyrosine	baseline, 3.0 mo	Change in antioxidant biomarker from baseline to 3 months
Change in plasma catalase	baseline, 3.0 mo	Change in antioxidant biomarker from baseline to 3 months

Trial Locations

Locations (1)

Southbay Pharma Research; 🇺🇸 Buena Park, California, United States