Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

Study Overview
=================
Brief Summary
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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.

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Mineral water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults, men and women >18 and ≤ 45 years Total-cholesterol > 200 mg/dL and < 300 mg/dL Exclusion Criteria: 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 Diabetes 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bicarbonated mineral water (BW)<br>Bicarbonated mineral water | Dietary Supplement: Mineral water<br>* Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design<br>|
| Active Comparator: Control mineral water (CW)<br>Mineral water low in mineral content (control) | Dietary Supplement: Mineral water<br>* Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol |  | Baseline | 
| LDL-cholesterol |  | 4 weeks | 
| LDL-cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total-cholesterol |  | Baseline | 
| Total-cholesterol |  | 4 weeks | 
| Total-cholesterol |  | 8 weeks | 
| Triglycerides |  | Baseline | 
| Triglycerides |  | 4 weeks | 
| Triglycerides |  | 8 weeks | 
| HDL-cholesterol |  | Baseline | 
| HDL-cholesterol |  | 4 weeks | 
| HDL-cholesterol |  | 8 weeks | 
| Apolipoprotein A |  | Baseline | 
| Apolipoprotein A |  | 4 weeks | 
| Apolipoprotein A |  | 8 weeks | 
| Apolipoprotein B |  | Baseline | 
| Apolipoprotein B |  | 4 weeks | 
| Apolipoprotein B |  | 8 weeks | 
| Glucose |  | Baseline | 
| Glucose |  | 4 weeks | 
| Glucose |  | 8 weeks | 
| Insulin |  | Baseline | 
| Insulin |  | 4 weeks | 
| Insulin |  | 8 weeks | 
| Urine creatinin |  | Baseline | 
| Urine creatinin |  | 8 weeks | 
| Urine calcium |  | Baseline | 
| Urine calcium |  | 8 weeks | 
| Urine potassium |  | Baseline | 
| Urine potassium |  | 8 weeks | 
| Urine sodium |  | Baseline | 
| Urine sodium |  | 8 weeks | 
| Urine pH |  | Baseline | 
| Urine pH |  | 8 weeks | 
| Systolic Blood Pressure |  | Baseline | 
| Systolic Blood Pressure |  | 4 weeks | 
| Systolic Blood Pressure |  | 8 weeks | 
| Diastolic Blood Pressure |  | Baseline | 
| Diastolic Blood Pressure |  | 4 weeks | 
| Diastolic Blood Pressure |  | 8 weeks | 
| Oxidized LDL |  | Baseline | 
| Oxidized LDL |  | 4 weeks | 
| Oxidized LDL |  | 8 weeks | 
| Serum aldosterone |  | Baseline | 
| Serum aldosterone |  | 8 weeks | 
| BMI |  | Baseline | 
| BMI |  | 4 weeks | 
| BMI |  | 8 weeks | 
| Dietary energy intake |  | Baseline | 
| Dietary energy intake |  | 8 weeks | 
| Dietary protein intake |  | Baseline | 
| Dietary protein intake |  | 8 weeks | 
| Dietary fat intake |  | Baseline | 
| Dietary fat intake |  | 8 weeks | 
| Dietary cholesterol intake |  | Baseline | 
| Dietary cholesterol intake |  | 8 weeks | 
| Dietary carbohydrate intake |  | Baseline | 
| Dietary carbohydrate intake |  | 8 weeks |