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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 (11SEHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137590
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Collaborator:
Standard Process Inc.
Information provided by (Responsible Party):
KGK Science Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Spanish Black Radish product Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spanish Black Radish
Spanish Black Radish product
Dietary Supplement: Spanish Black Radish product



Primary Outcome Measures :
  1. Effect on Phase I and II enzymes [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Assessment of Hormone Levels [ Time Frame: 4 weeks ]
    Assessment of serum total testosterone, free testosterone and estradiol 17 beta


Other Outcome Measures:
  1. Blood Safety Parameters [ Time Frame: 4 weeks ]
    Assessment of CBC, electrolytes (Na, K, Cl), creatinine, AST, ALT, GGT, and bilirubin

  2. Vital Signs [ Time Frame: 4 weeks ]
    Assessment of Blood Pressure and Heart Rate

  3. Adverse Events [ Time Frame: 4 weeks ]
    Assessment of any adverse events occurring during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137590


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
Standard Process Inc.
Investigators
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Principal Investigator: Dale Wilson, MD KGK Science Inc.
Study Director: Malkanthi Evans, PhD KGK Science Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02137590    
Other Study ID Numbers: 11SEHS
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Keywords provided by KGK Science Inc.:
Spanish Black Radish
Phase I detoxification enzymes
Phase II detoxification enzymes
Acetaminophen