Mechanism of Action of Vichy Catalan Water

This study has been completed.
Sponsor:
Collaborator:
Vichy Catalán, Spain
Information provided by:
National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT01334840
First received: April 12, 2011
Last updated: July 29, 2014
Last verified: April 2011
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Dietary Supplement: Bicarbonated mineral water
Dietary Supplement: Mineral water low in mineral content (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanism of Action of Vichy Catalan Water

Resource links provided by NLM:


Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • Serum triacylglycerols [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Serum triacylglycerols [ Time Frame: Postprandial 30 minutes ] [ Designated as safety issue: No ]
  • Serum triacylglycerols [ Time Frame: Postprandial 60 minutes ] [ Designated as safety issue: No ]
  • Serum triacylglycerols [ Time Frame: Postprandial 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum glucose [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Serum glucose [ Time Frame: Postprandial 30 minutes ] [ Designated as safety issue: No ]
  • Serum glucose [ Time Frame: Postprandial time 60 minutes ] [ Designated as safety issue: No ]
  • Serum glucose [ Time Frame: Postprandial time 120 minutes ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: Postprandial 30 minutes ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: Postprandial 60 minutes ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: Postprandial 120 minutes ] [ Designated as safety issue: No ]
  • Cholecystokinin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cholecystokinin [ Time Frame: Postprandial 30 minutes ] [ Designated as safety issue: No ]
  • Cholecystokinin [ Time Frame: Postprandial 60 minutes ] [ Designated as safety issue: No ]
  • Cholecystokinin [ Time Frame: Postprandial 120 minutes ] [ Designated as safety issue: No ]
  • Gallbladder volume [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Gallbladder volume [ Time Frame: Postprandial 15 minutes ] [ Designated as safety issue: No ]
  • Gallbladder volume [ Time Frame: Postprandial 30 minutes ] [ Designated as safety issue: No ]
  • Gallbladder volume [ Time Frame: Postprandial 60 minutes ] [ Designated as safety issue: No ]
  • Gallbladder volume [ Time Frame: Postprandial 120 minutes ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: Postprandial 30 minutes ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: Postprandial 60 minutes ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: Postprandial 120 minutes ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BW
Bicarbonated mineral water without meal
Dietary Supplement: Bicarbonated mineral water

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
Dietary Supplement: Bicarbonated mineral water

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
Dietary Supplement: Mineral water low in mineral content (control)

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
Dietary Supplement: Mineral water low in mineral content (control)

Volunteers fasted overnight consumed:

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


  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334840

Locations
Spain
Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)
Madrid, Spain, 28040
Sponsors and Collaborators
National Research Council, Spain
Vichy Catalán, Spain
Investigators
Principal Investigator: M Pilar Vaquero, Dr National Research Council, Spain
  More Information

Publications:

Responsible Party: M Pilar Vaquero, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01334840     History of Changes
Other Study ID Numbers: BW-09
Study First Received: April 12, 2011
Last Updated: July 29, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by National Research Council, Spain:
Cardiovascular risk
Cholecystokinin
Gallbladder emptying
Lipid absorption
Postprandial triacylglycerols
Sodium-bicarbonated mineral water

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014