NCT01819636已完成不适用
Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile
Neptune3 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2013年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Fasting plasma triglyceride
研究概览
简要总结
The aim of the study is to assess the beneficial effect of the short term consumption of the highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low mineralized water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 to 70 years (limits included) ;
- •With a BMI between 18,5 (limit excluded) and 35 kg/m² (limit excluded) ;
- •Menopausal female without hormone replacement therapy or with stable hormone replacement therapy since at least 3 months or non-menopausal female with reliable contraception since at least two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study;
- •Without changes in food habits and physical activity during the last 3 months and agreeing not to change them throughout the study
- •Tolerating sparkling mineral water consumption instead of usual water during 8 weeks
- •Fasting blood triglycerides level between 1 and 3,5 g/L (limits included);
- •Fasting total cholesterol < 3g/L;
- •Fasting blood glucose level < 1,26 g/L.
排除标准
- •Known or suspected food allergy or intolerance to one of the tested products' components or to related products ;
- •Consuming more than 2 alcoholic drinks daily;
- •Smoking more than 10 cigarettes daily ;
- •Following an extreme or exclusive diet (vegetarian, vegan ...)
- •With personal history of anorexia nervosa, bulimia or eating disorders;
- •With a body weight variation > 5 kg in the last 3 months;
- •Having a lifestyle deemed incompatible with the study according to the investigator;
- •With metabolic disorders such as diabetes or other chronic severe disease ;
- •Suffering from uncontrolled hypertension;
- •With severe chronic disease (cancer, HIV, renal failure, liver disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory failure, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator ;
- •Pregnant or breastfeeding women or intending to become pregnant within 4 months ahead ;
- •Under lipid-lowering therapy or stopped for less than 6 weeks for statins or fibrates and less than 6 months for niacin;
- •Eating foodstuffs or dietary supplements that may interfere with lipid metabolism (red yeast rice, policosanol, omega-3 fatty acids, plant stanol or sterol) or consuming them steadily over the last 4 weeks;
- •Using of medications which could affect lipid absorption or/and metabolism (long-term corticosteroid treatment);
- •Using a treatment which may interfere with the evolution of the parameters studied according to the investigator;
- •Who made a blood donation in the last 3 months or intending to make it within 4 months ahead ;
- •Taking part in an-other clinical trial or being in the exclusion period of a previous clinical trial.
- •A re-screening can occur from 2 months after the exit of study for failure to comply with the one or more of the eligibility criteria listed above.
研究组 & 干预措施
Sparkling highly mineral bicarbonated sodium water
Experimental
1.25 liter a day of sparkling highly mineral bicarbonated sodium water
干预措施: sparkling highly mineral bicarbonated sodium water (Other)
Sparkling low mineralized water
Placebo Comparator
1.25 liter a day of sparkling low mineralized water
结局指标
主要结局
Fasting plasma triglyceride
时间窗: 4 weeks
次要结局
- Bilirubin(8 weeks)
- Complete blood count(8 weeks)
- Fasting plasma glucose(4 and 8 weeks)
- Heart rate(4 and 8 weeks)
- Gamma Glutamyl Transferase(8 weeks)
- Fasting plasma triglyceride(8 weeks)
- Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides(0 and 8 weeks)
- Fasting plasma Low Density Lipoprotein cholesterol(4 and 8 weeks)
- Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol(0 and 8 weeks)
- Delta peak between T0 and T480min of plasma total cholesterol(0 and 8 weeks)
- Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol(0 and 8 weeks)
- Fasting plasma High Density Lipoprotein cholesterol(4 and 8 weeks)
- Cmax between T0 and T480min of plasma triglyceride(0 and 8 weeks)
- Fasting plasma total cholesterol(4 and 8 weeks)
- Systolic Blood Pressure(4 and 8 weeks)
- Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol(0 and 8 weeks)
- Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol(0 and 8 weeks)
- Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol(0 and 8 weeks)
- Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol(0 and 8 weeks)
- Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol(0 and 8 weeks)
- Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol(0 and 8 weeks)
- Kinetic between T0 and T480min of plasma total cholesterol(0 and 8 weeks)
- Kinetic between T0 and T480min of plasma triglycerides(0 and 8 weeks)
- Delta peak between T0 and T480min of plasma triglycerides(0 and 8 weeks)
- Plasmatic potassium(4 and 8 weeks)
- Plasmatic Chloride(4 and 8 weeks)
- Diastolic Blood Pressure(4 and 8 weeks)
- Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol(0 and 8 weeks)
- Cmax between T0 and T480min of plasma total cholesterol(0 and 8 weeks)
- Aspartate Amino Transferase(4 and 8 weeks)
- Alanine Amino Transferase(4 and 8 weeks)
- Plasmatic urea(4 and 8 weeks)
- Plasmatic creatinine(4 and 8 weeks)
- Plasmatic sodium(4 and 8 weeks)
研究者
研究点 (3)
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