临床试验/NCT02137590

NCT02137590已完成1 期

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

KGK Science Inc.2 个研究点分布在 1 个国家目标入组 20 人开始时间: 2011年9月最近更新: 2014年5月14日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: KGK Science Inc.
入组人数: 20
试验地点: 2
主要终点: Effect on Phase I and II enzymes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
盲法: None

入排标准

年龄范围: 25 Years 至 35 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•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

排除标准

•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.

结局指标

主要结局

Effect on Phase I and II enzymes

时间窗: 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.

次要结局

Assessment of Hormone Levels(4 weeks)

研究者

发起方

KGK Science Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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