NCT01083771已完成不适用
Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet
研究概览
简要总结
The purpose of this study is to assess for changes in a patient's overall energy level and well-being (quality of life) after 8 weeks of dietary intervention.
详细描述
Primary Objective: To assess for changes in the following measurements after 8 weeks of following a Mediterranean diet-- LDL, HDL, TG, FBS, creatinine, serum testosterone, triglycerides, serum insulin, CRP, 1bs, Waist circumference, blood pressure, body weight
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically documented carcinoma of the prostate
- •On treatment with androgen deprivation therapy for at least 3 months
- •Required laboratory values:
- •Serum creatinine less than 2.5
- •Triglycerides <300
- •Fasting glucose < 126
- •Testosterone level <50
排除标准
- •No diabetes mellitus (Type 1 or 2)
- •No renal failure (Serum creatinine > 2.5)
- •No active cardiac disease -no history of myocardial infarction/stroke within the last 12 months, no recurrent unstable angina, uncontrolled/unstable arrhythmias, uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >100)
- •No severe peripheral vascular disease
- •No commencement of lipid lowering agent within 8 weeks of enrollment the study or change in dose throughout the study
结局指标
主要结局
Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet
时间窗: eight weeks
Based on overall percentage change at baseline versus post diet
次要结局
- To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet(8 weeks)
研究者
研究点 (2)
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