ABG Oxidative Stress Study Protocol-1

NCT02213523 | Completed DMC

• 1 other identifier: ABG AOX-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is a proof of concept study that evaluates the response to oxidative stress in healthy men after taking plant concentrates.

Conditions

Healthy

Keywords

antioxidant

Outcome Measures

Primary Outcomes (1)

• Change in urine 8-isoprostane

  Change in antioxidant biomarker from baseline to day 15

  Day 1, 15

Secondary Outcomes (4)

• Change in erythrocyte Superoxide Dismutase

  1, 15

• Change in plasma malondialdehyde

  Day 1, 15

• Plasma hemoxygenase-1

  Day 1, 15

• Erythrocyte glutathione peroxidase

  Day 1, 15

Study Arms (4)

Plant concentrate A

EXPERIMENTAL

Plant concentrate A containing Rosemary:Quercetin:Turmeric 5:3:1 Low dose (300 mg) to high dose (600 mg)

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)

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)

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)

Dietary Supplement: Plant concentrate D

Interventions

Plant concentrate A DIETARY_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 A

Plant concentrate B DIETARY_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 B

Plant concentrate C DIETARY_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 C

Plant concentrate D DIETARY_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 D

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Access Business Group: lead

Study Sites (2)

Quality of Life

Buena Park, California, 90620, United States

Location

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2013
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (2)