An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes

Study Overview
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Brief Summary
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This study will investigate the effect of Spanish Black Radish on phase I and phase II enzyme activity in healthy adult males. The primary objective is to determine the effect on phase I and phase II enzyme activity by measuring plasma and urine acetaminophen metabolite concentrations prior to and after a 28 day supplementation period with Spanish black radish product.

Official Title
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An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Spanish Black Radish product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male age 25 - 35 years BMI 18 - 25 kg/m2 Healthy as determined by laboratory results, medical history Agrees to avoid the consumption of cruciferous vegetables for 14 days prior to baseline and during the study treatment period Has given voluntary, written, informed consent to participate in the study Exclusion Criteria: Chronic diseases or any medical conditions Gall bladder disorders and /or bowel obstruction Use of prescribed or over the counter medications for the treatment of any acute or chronic conditions Use of muscle building steroids or body building aids Use of products containing ingredients derived from the Cruciferae (Brassicaracea) plant family within 14 days prior to randomization Use of natural health products other than vitamins or minerals within 14 days prior to randomization Any clinically significant abnormal laboratory value. Meaning a disease process, an exacerbation or worsening of an existing condition, requires further or more frequent monitoring or requires further action(s) to be taken. Clinical significance can only be determined by the Qualified Investigator. Participation in a clinical research trial within 30 days prior to randomization Allergy or sensitivity to test product ingredients, Cruciferae/Brassicaracea plant family (includes mustard, cabbage, radish), acetaminophen or foods and beverages provided during the study Individuals who are cognitively impaired and/or who are unable to give informed consent Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject Cannot take acetaminophen within 48 hrs of the baseline appointment or final 4-wk appointment.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spanish Black Radish<br>Spanish Black Radish product | Dietary Supplement: Spanish Black Radish product<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Phase I and II enzymes | The effect on phase I and phase II enzyme activity determined by measuring plasma and urine acetaminophen metabolite concentrations Subjects will ingest 1000 mg of acetaminophen. Blood will be collected at 0, 2, 4, 6 and 8 hours after acetaminophen dosage for the analysis of plasma acetaminophen metabolites. These measurements will be performed prior to and after 4 weeks of treatment with Spanish Black Radish product. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Hormone Levels | Assessment of serum total testosterone, free testosterone and estradiol 17 beta | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spanish Black Radish, Phase I detoxification enzymes, Phase II detoxification enzymes, Acetaminophen