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

Study Overview
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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.

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.

Official Title
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A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: 1 tablet composed of antioxidants and minerals


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antioxidant Supplements<br> | Dietary Supplement: 1 tablet composed of antioxidants and minerals<br>* 1 tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a base line level for 5 DNA modifications of White blood cells |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antioxidant supplement