Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.

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Detailed Description

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In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antioxidant Supplements

Group Type EXPERIMENTAL

1 tablet composed of antioxidants and minerals

Intervention Type DIETARY_SUPPLEMENT

1 tablet daily

Interventions

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1 tablet composed of antioxidants and minerals

1 tablet daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Health male or female non-melanoma patients or volunteers
* 18 years or older with a life expectancy greater than 6 months
* Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
* Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
* Must have never smoked or has not smoked for at least 6 months
* Informed of the investigational nature of the study, is able to provide informed consent and has signed thee informed consent form

Exclusion Criteria

* Patients/healthy volunteers not meeting all of the above selection criteria.
* Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
* Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
* Patients not willing to comply with protocol requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes