Mechanism of Action of Vichy Catalan Water

Study Overview
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Brief Summary
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Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated mineral waters are reported to have beneficial digestive and hypocholesterolemic properties. The aim of this study was to investigate the effects of the consumption of a sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral content water as a control water (CW), on postprandial serum triacylglycerols (TAG), cholecystokinin (CCK), and gallbladder volume.

Official Title
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Mechanism of Action of Vichy Catalan Water

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Bicarbonated mineral water
* Dietary Supplement: Mineral water low in mineral content (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>18 and <40 years) BMI >18 and <30 kg/m2 Exclusion Criteria: Age <18 and > 40 years TAG > 250 mg/dL (2.82 mmol/L) Being a usual consumer of carbonic mineral water Obesity Diabetes Hypertension or digestive, liver and renal disease Biliary obstruction 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: 40 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: BW<br>Bicarbonated mineral water without meal | Dietary Supplement: Bicarbonated mineral water<br>* Volunteers fasted overnight consumed: 0.5 L of the bicarbonated mineral water without meal or, 0.5 L of the bicarbonated mineral water with meal<br>|
| Experimental: BW with meal<br>Bicarbonated mineral water with meal | Dietary Supplement: Bicarbonated mineral water<br>* Volunteers fasted overnight consumed: 0.5 L of the bicarbonated mineral water without meal or, 0.5 L of the bicarbonated mineral water with meal<br>|
| Active Comparator: CW<br>Mineral water low in mineral content (control) without meal | Dietary Supplement: Mineral water low in mineral content (control)<br>* Volunteers fasted overnight consumed: 0.5 L of the control water without meal or, 0.5 L of the control water with meal<br>|
| Active Comparator: CW with meal<br>Mineral water low in mineral content (control) with a meal | Dietary Supplement: Mineral water low in mineral content (control)<br>* Volunteers fasted overnight consumed: 0.5 L of the control water without meal or, 0.5 L of the control water with meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum triacylglycerols |  | Baseline | 
| Serum triacylglycerols |  | Postprandial 30 minutes | 
| Serum triacylglycerols |  | Postprandial 60 minutes | 
| Serum triacylglycerols |  | Postprandial 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum glucose |  | Baseline | 
| Serum glucose |  | Postprandial 30 minutes | 
| Serum glucose |  | Postprandial time 60 minutes | 
| Serum glucose |  | Postprandial time 120 minutes | 
| Serum insulin |  | Baseline | 
| Serum insulin |  | Postprandial 30 minutes | 
| Serum insulin |  | Postprandial 60 minutes | 
| Serum insulin |  | Postprandial 120 minutes | 
| Cholecystokinin |  | Baseline | 
| Cholecystokinin |  | Postprandial 30 minutes | 
| Cholecystokinin |  | Postprandial 60 minutes | 
| Cholecystokinin |  | Postprandial 120 minutes | 
| Gallbladder volume |  | Baseline | 
| Gallbladder volume |  | Postprandial 15 minutes | 
| Gallbladder volume |  | Postprandial 30 minutes | 
| Gallbladder volume |  | Postprandial 60 minutes | 
| Gallbladder volume |  | Postprandial 120 minutes | 
| Aldosterone |  | Baseline | 
| Aldosterone |  | Postprandial 30 minutes | 
| Aldosterone |  | Postprandial 60 minutes | 
| Aldosterone |  | Postprandial 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular risk, Cholecystokinin, Gallbladder emptying, Lipid absorption, Postprandial triacylglycerols, Sodium-bicarbonated mineral water