HealthyPhase 111SEHSNCT02137590
An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes
A Phase 1 study testing Spanish Black Radish product in people with Healthy, run by KGK Science Inc. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Spanish Black Radish product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Spanish Black Radish product
- Keywords
- Spanish Black Radish, Phase I detoxification enzymes, Phase II detoxification enzymes, Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish Black Radish productDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Spanish Black Radish | Experimental | Spanish Black Radish product Receives: Dietary Supplement: Spanish Black Radish product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Assessment of Hormone Levels
Assessment of serum total testosterone, free testosterone and estradiol 17 beta
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Standard Process Inc.
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, MD, Principal investigator, KGK Science Inc.Malkanthi Evans, PhD, Study director, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137590
- Sponsor's protocol ID
- 11SEHS
- Acronym
- 11SEHS
- Status last verified
- May 2014
- First submitted
- 12 May 2014
- Last updated
- 14 May 2014
- Results posted
- No
Publications
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.
PubMed 25490898
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02137590
- Acronym / sponsor ID
- 11SEHS / 11SEHS
- Conditions
- Healthy
- Keywords
- Spanish Black Radish, Phase I detoxification enzymes, Phase II detoxification enzymes, Acetaminophen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Standard Process Inc.
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish Black Radish | Experimental | Dietary Supplement: Spanish Black Radish productSpanish Black Radish product |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spanish Black Radish product | Dietary supplement | Spanish Black Radish |
Primary outcome
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.
1 secondary outcome
Assessment of Hormone Levels
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
- Derived from this study: PubMed 25490898Evans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Wilson, MD principal investigator
KGK Science Inc.
Malkanthi Evans, PhD study director
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spanish Black Radish product in people with Healthy, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on Phase I and II enzymes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.