Mechanism of Action of Vichy Catalan Water

July 29, 2014 updated by: National Research Council, Spain
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28040
        • Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BW
Bicarbonated mineral water without meal

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

Experimental: BW with meal
Bicarbonated mineral water with meal

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

Active Comparator: CW
Mineral water low in mineral content (control) without meal

Volunteers fasted overnight consumed:

0.5 L of the control water without meal or, 0.5 L of the control water with meal

Active Comparator: CW with meal
Mineral water low in mineral content (control) with a meal

Volunteers fasted overnight consumed:

0.5 L of the control water without meal or, 0.5 L of the control water with meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum triacylglycerols
Time Frame: Baseline
Baseline
Serum triacylglycerols
Time Frame: Postprandial 30 minutes
Postprandial 30 minutes
Serum triacylglycerols
Time Frame: Postprandial 60 minutes
Postprandial 60 minutes
Serum triacylglycerols
Time Frame: Postprandial 120 minutes
Postprandial 120 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: M Pilar Vaquero, Dr, National Research Council, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

April 1, 2011

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Bicarbonated mineral water

3
Subscribe