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

NCT ID: NCT02137590

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Spanish Black Radish

Spanish Black Radish product

Group Type: EXPERIMENTAL

Spanish Black Radish product

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Spanish Black Radish product

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Standard Process Inc.

INDUSTRY

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dale Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Malkanthi Evans, PhD

Role: STUDY_DIRECTOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25490898 (View on PubMed)

Other Identifiers

11SEHS

Identifier Type: -

Identifier Source: org_study_id