NCT03090542已完成不适用
39 Day Randomized, Open Label, Two Arm Cross Over Study of Clinoptilolite (Gpur) in Healthy Adult Subjects Not Requiring or Receiving Lipid Lowering Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days
研究概览
简要总结
In healthy subjects not receiving or requiring lipid lowering therapy and who do not have diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary cholesterol observed over 6 days of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over 18 years of age
- •Not receiving or requiring lipid lowering therapy
- •Willingness to give informed consent
- •Able to keep a dietary log
- •Willing to maintain a consistent day to day routine during the study (no major changes in lifestyle, exercise, food pattern, smoking habits, etc)
排除标准
- •Current use of oral lipid binding agents (colesevelam, cholestyramine, ezetimibe) fibrates, niacin or statins
- •Current use of dietary supplements enriched with fat soluble vitamins, mono/polyunsaturated fat (fish-oil etc.) or probiotics
- •Any oral antibiotic use, currently or within the past 14 days
- •Diabetes, Type I and Type II
- •Currently following a restrictive diet
- •GI motility disorders (irritable bowel syndrome, diabetic gastroparesis, etc)
- •Prior gastric or bowel resection
- •Inflammatory bowel disease (Crohns, ulcerative colitis, diverticulitis, celiac sprue, etc)
- •Co-morbidities with anticipated life expectancy < 12 months
- •ESRD on dialysis
- •Known intolerance to silicium or aluminum compounds
- •Excess alcohol consumption (>1 drink per day)
- •Pregnancy, nursing or not taking/using contraception
- •Hepatobiliary disorders or renal disease
- •Plasma total cholesterol > 240mg/dl or Triglycerides > 265.5 mg/dl
- •No plant-sterol enriched food products allowed in diet & supplements
- •BMI > 35
研究组 & 干预措施
Control
No Intervention
Product
Active Comparator
干预措施: clinoptilolite (Dietary Supplement)
结局指标
主要结局
Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days
时间窗: 39 days
Primary Objective
次要结局
- Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates(39 days)
- Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements(39 days)
研究者
研究点 (2)
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