Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

Study Overview
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Brief Summary
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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.

Official Title
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Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Other: sparkling highly mineral bicarbonated sodium water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sparkling highly mineral bicarbonated sodium water<br>1.25 liter a day of sparkling highly mineral bicarbonated sodium water | Other: sparkling highly mineral bicarbonated sodium water<br>* 1,25 liter a day at the mealtimes<br>|
| Placebo Comparator: Sparkling low mineralized water<br>1.25 liter a day of sparkling low mineralized water | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma triglyceride |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma total cholesterol |  | 4 and 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 High Density Lipoprotein cholesterol |  | 4 and 8 weeks | 
| Fasting plasma Low Density Lipoprotein cholesterol |  | 4 and 8 weeks | 
| Fasting plasma glucose |  | 4 and 8 weeks | 
| Heart rate |  | 4 and 8 weeks | 
| Systolic Blood Pressure |  | 4 and 8 weeks | 
| Diastolic Blood Pressure |  | 4 and 8 weeks | 
| Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol |  | 0 and 8 weeks | 
| Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol |  | 0 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 triglyceride |  | 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 total 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 | 
| 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 | 
| 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 | 
| Alanine Amino Transferase |  | 4 and 8 weeks | 
| Aspartate Amino Transferase |  | 4 and 8 weeks | 
| Plasmatic urea |  | 4 and 8 weeks | 
| Plasmatic creatinine |  | 4 and 8 weeks | 
| Plasmatic potassium |  | 4 and 8 weeks | 
| Plasmatic sodium |  | 4 and 8 weeks | 
| Plasmatic Chloride |  | 4 and 8 weeks | 
| Gamma Glutamyl Transferase |  | 8 weeks | 
| Bilirubin |  | 8 weeks | 
| Complete blood count |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood triglyceride, Bicarbonated mineral wate, Post-prandial triglyceridemia, lipid metabolism, Cardiovascular risk