Clinical trial NCT02137590: An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Spanish Black Radish
Phase I detoxification enzymes
Phase II detoxification enzymes
Acetaminophen
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Standard Process Inc.
First posted: 2014-05-14
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


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.

Primary outcomes:
measure: Effect on Phase I and II enzymes
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessment of Hormone Levels
timeFrame: 4 weeks
Other outcomes:
measure: Blood Safety Parameters
timeFrame: 4 weeks
measure: Vital Signs
timeFrame: 4 weeks
measure: Adverse Events
timeFrame: 4 weeks
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Dale Wilson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KGK Science Inc.
name: Malkanthi Evans, PhD
role: STUDY_DIRECTOR
References:
citation: 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.