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| Name | Class |
|---|---|
| Standard Process Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spanish Black Radish | Experimental | Spanish Black Radish product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spanish Black Radish product | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Hormone Levels | Assessment of serum total testosterone, free testosterone and estradiol 17 beta | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Safety Parameters | Assessment of CBC, electrolytes (Na, K, Cl), creatinine, AST, ALT, GGT, and bilirubin | 4 weeks |
| Vital Signs | Assessment of Blood Pressure and Heart Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Wilson, MD | KGK Science Inc. | Principal Investigator |
| Malkanthi Evans, PhD | KGK Science Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25490898 | Derived | 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. |
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| 4 weeks |
| Adverse Events | Assessment of any adverse events occurring during the study | 4 weeks |