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

NCT02137590 | Completed Phase 1

• 1 other identifier: 11SEHS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Spanish Black Radish; Phase I detoxification enzymes; Phase II detoxification enzymes; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Hormone Levels

  4 weeks

Other Outcomes (3)

• Blood Safety Parameters

  4 weeks

• Vital Signs

  4 weeks

• Adverse Events

  4 weeks

Study Arms (1)

Spanish Black Radish

EXPERIMENTAL

Spanish Black Radish product

Dietary Supplement: Spanish Black Radish product

Interventions

Spanish Black Radish product DIETARY_SUPPLEMENT

Spanish Black Radish

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KGK Science Inc.: lead
• Standard Process Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 25490898 DERIVED

Study Officials

• Dale Wilson, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

• Malkanthi Evans, PhD

  KGK Science Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

CA (1)