NCT02480816已完成不适用
Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
National Research Council, Spain0 个研究点目标入组 72 人开始时间: 2015年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- LDL-cholesterol
研究概览
简要总结
The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium, chloride, lithium and silicon are studied in humans. The aim of this assay was to determine whether the consumption of this water as part of the usual diet, reduces cardiometabolic risk factors in adult men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, men and women >18 and ≤ 45 years
- •Total-cholesterol > 200 mg/dL and < 300 mg/dL
排除标准
- •Age <18 and > 45 years
- •Total-cholesterol ≥300 mg/dL
- •Triglycerides > 250 mg/dL
- •Total-cholesterol / HDL-cholesterol > 6
- •Being a usual consumer of carbonic mineral water
- •BMI < 20 and >30 kg/m2
- •Hypertension or digestive, liver or renal disease
- •Eating disorders
- •Being under medication that could affect lipid metabolism
- •Consumption of functional foods that could affect lipid metabolism (food containing n-3 fatty acids or phytosterols)
结局指标
主要结局
LDL-cholesterol
时间窗: 8 weeks
次要结局
- Total-cholesterol(8 weeks)
- Triglycerides(8 weeks)
- HDL-cholesterol(8 weeks)
- Apolipoprotein A(8 weeks)
- Insulin(8 weeks)
- Urine pH(8 weeks)
- Serum aldosterone(8 weeks)
- BMI(8 weeks)
- Dietary protein intake(8 weeks)
- Dietary fat intake(8 weeks)
- Glucose(8 weeks)
- Oxidized LDL(8 weeks)
- Dietary energy intake(8 weeks)
- Dietary cholesterol intake(8 weeks)
- Apolipoprotein B(8 weeks)
- Urine potassium(8 weeks)
- Urine sodium(8 weeks)
- Systolic Blood Pressure(8 weeks)
- Diastolic Blood Pressure(8 weeks)
- Urine creatinin(8 weeks)
- Urine calcium(8 weeks)
- Dietary carbohydrate intake(8 weeks)
研究者
M Pilar Vaquero
Scientific researcher
National Research Council, Spain
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