Skip to main content
OpenTrials
Completed

NCT Number: NCT02137590

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spanish Black Radish product

Dietary Supplement

Primary outcomes

  1. Effect on Phase I and II enzymes

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Assessment of Hormone Levels

    Time frame: 4 weeks

    Assessment of serum total testosterone, free testosterone and estradiol 17 beta

Other outcomes

  1. Blood Safety Parameters

    Time frame: 4 weeks

    Assessment of CBC, electrolytes (Na, K, Cl), creatinine, AST, ALT, GGT, and bilirubin

  2. Vital Signs

    Time frame: 4 weeks

    Assessment of Blood Pressure and Heart Rate

  3. Adverse Events

    Time frame: 4 weeks

    Assessment of any adverse events occurring during the study

Sponsors and collaborators

Lead sponsor

KGK Science Inc.

Industry

Collaborators

  • Standard Process Inc.

Registry information

Official study 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

Acronym: 11SEHS

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 14, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.