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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Spanish Black Radish product

• Registration Number: NCT02137590
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Study First Posted: 2014-05-14
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spanish Black Radish	Spanish Black Radish product	Spanish Black Radish product

Primary Outcome Measures

Name	Time	Method
Effect on Phase I and II enzymes	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

Name	Time	Method
Assessment of Hormone Levels	4 weeks	Assessment of serum total testosterone, free testosterone and estradiol 17 beta

Trial Locations

Locations (1)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada