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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01645-38 | Registry Identifier | ID RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sparkling highly mineral bicarbonated sodium water | Experimental | 1.25 liter a day of sparkling highly mineral bicarbonated sodium water |
|
| Sparkling low mineralized water | Placebo Comparator | 1.25 liter a day of sparkling low mineralized water |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sparkling highly mineral bicarbonated sodium water | Other | 1,25 liter a day at the mealtimes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma triglyceride | 4 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PCSK9 protein | 4 and 8 weeks | |
| High Density Lipoprotein cholesterol efflux | 4 and 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| David Gendre, PhD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPTIMED | Gières | 38610 | France | |||
| Naturalpha |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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 |
| Lille |
| 59020 |
| France |
| Biofortis | Saint-Herblain | 44800 | France |
| D009750 |
| Nutritional and Metabolic Diseases |