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

Healthy Clinical Trial

— 11SEHS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137590
• Other study ID #: 11SEHS
• Status: Completed
• Phase: Phase 1
• First received: May 12, 2014
• Last updated: May 13, 2014
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2014
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 35 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Spanish Black Radish product

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Standard Process Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Safety Parameters	Assessment of CBC, electrolytes (Na, K, Cl), creatinine, AST, ALT, GGT, and bilirubin	4 weeks	Yes
Other	Vital Signs	Assessment of Blood Pressure and Heart Rate	4 weeks	Yes
Other	Adverse Events	Assessment of any adverse events occurring during the study	4 weeks	Yes
Primary	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	No
Secondary	Assessment of Hormone Levels	Assessment of serum total testosterone, free testosterone and estradiol 17 beta	4 weeks	No