NCT00449462已完成不适用
The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- creatinine clearance
研究概览
简要总结
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.
The CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.
详细描述
Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-60 years
- •serum total cholesterol < 8.0 mmol/L
- •serum triglycerides < 3.0 mmol/L
- •ALAT < 45 IU/L
- •ASAT < 41 IU/L
- •amylase 35-130 U/L
- •alkaline phosphatase 40-125 U/L
- •bilirubin < 17 µmol/L
- •gamma-glutamyltranspeptidase > 75 U/L (men) and < 40 U/L (women)
- •lactate dehydrogenase 230-485 U/L
- •creatinine clearance >= 90 mL/min
- •fasting glucose levels 70-115 mg/dL
- •fasting insulin levels 5-30 mU/L
排除标准
- •use of cholesterol lowering medication
- •high alcohol intake
- •BMI > 30
- •chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- •pregnancy
结局指标
主要结局
creatinine clearance
amylase
bilirubin
alkaline phosphatase
gamma-glutamyltranspeptidase
lactate dehydrogenase
ASAT
ALAT
次要结局
- total cholesterol
- HDL cholesterol
- LDL cholesterol
- triglycerides
- fatty acids
研究者
研究点 (2)
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