An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes (11SEHS)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Spanish Black Radish product

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Spanish Black Radish; Spanish Black Radish product	Dietary supplement: Spanish Black Radish product

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Safety Parameters	Assessment of CBC, electrolytes (Na, K, Cl), creatinine, AST, ALT, GGT, and bilirubin	4 weeks
Vital Signs	Assessment of Blood Pressure and Heart Rate	4 weeks
Adverse Events	Assessment of any adverse events occurring during the study	4 weeks

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Standard Process Inc.
• Investigators: Study Director: Malkanthi Evans, PhD, KGK Science Inc.

Publications and helpful links

General Publications

• Evans M, Paterson E, Barnes DM. 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. BMC Complement Altern Med. 2014 Dec 9;14:475. doi: 10.1186/1472-6882-14-475.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (ESTIMATE): May 14, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Acetaminophen; Spanish Black Radish; Phase I detoxification enzymes; Phase II detoxification enzymes
• Other Study ID Numbers: 11SEHS