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Mechanism of Action of Vichy Catalan Water

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334840
First Posted: April 13, 2011
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vichy Catalán, Spain
Information provided by:
National Research Council, Spain
  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 (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 ]
  • Serum triacylglycerols [ Time Frame: Postprandial 30 minutes ]
  • Serum triacylglycerols [ Time Frame: Postprandial 60 minutes ]
  • Serum triacylglycerols [ Time Frame: Postprandial 120 minutes ]

Secondary Outcome Measures:
  • Serum glucose [ Time Frame: Baseline ]
  • Serum glucose [ Time Frame: Postprandial 30 minutes ]
  • Serum glucose [ Time Frame: Postprandial time 60 minutes ]
  • Serum glucose [ Time Frame: Postprandial time 120 minutes ]
  • Serum insulin [ Time Frame: Baseline ]
  • Serum insulin [ Time Frame: Postprandial 30 minutes ]
  • Serum insulin [ Time Frame: Postprandial 60 minutes ]
  • Serum insulin [ Time Frame: Postprandial 120 minutes ]
  • Cholecystokinin [ Time Frame: Baseline ]
  • Cholecystokinin [ Time Frame: Postprandial 30 minutes ]
  • Cholecystokinin [ Time Frame: Postprandial 60 minutes ]
  • Cholecystokinin [ Time Frame: Postprandial 120 minutes ]
  • Gallbladder volume [ Time Frame: Baseline ]
  • Gallbladder volume [ Time Frame: Postprandial 15 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 30 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 60 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 120 minutes ]
  • Aldosterone [ Time Frame: Baseline ]
  • Aldosterone [ Time Frame: Postprandial 30 minutes ]
  • Aldosterone [ Time Frame: Postprandial 60 minutes ]
  • Aldosterone [ Time Frame: Postprandial 120 minutes ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Toxqui L, Pérez-Granados AM, Blanco-Rojo R, Vaquero MP. A sodium-bicarbonated mineral water reduces gallbladder emptying and postprandial lipaemia: a randomised four-way crossover study. Eur J Nutr. 2012 Aug;51(5):607-14. doi: 10.1007/s00394-011-0244-x. Epub 2011 Sep 13.
Toxqui L, Pérez-Granados AM, Blanco-Rojo R, Vaquero MP. Effects of an alkaline mineral water on cholecystokinin levels and gallbladder emptying in young adults. Ann Nutr Metab 58(suppl 3):352-353,2011
Toxqui L, Pérez-Granados AM, Blanco-Rojo R, Vaquero MP. Sodium-bicarbonated mineral water reduces postprandial lipaemia in moderately hypercholesterolaemic young adults. Proceedings of the Nutrition Society 70 (OCE4):E245, 2011.
Schoppen S, Pérez-Granados AM, Carbajal A, Oubiña P, Sánchez-Muniz FJ, Gómez-Gerique JA, Vaquero MP. A sodium-rich carbonated mineral water reduces cardiovascular risk in postmenopausal women. J Nutr. 2004 May;134(5):1058-63.
Schoppen S, Pérez-Granados AM, Carbajal A, de la Piedra C, Pilar Vaquero M. Bone remodelling is not affected by consumption of a sodium-rich carbonated mineral water in healthy postmenopausal women. Br J Nutr. 2005 Mar;93(3):339-44.
Schoppen S, Pérez-Granados AM, Carbajal A, Sarriá B, Sánchez-Muniz FJ, Gómez-Gerique JA, Pilar Vaquero M. Sodium bicarbonated mineral water decreases postprandial lipaemia in postmenopausal women compared to a low mineral water. Br J Nutr. 2005 Oct;94(4):582-7.
Schoppen S, Pérez-Granados AM, Carbajal A, Sarriá B, Navas-Carretero S, Pilar Vaquero M. Sodium-bicarbonated mineral water decreases aldosterone levels without affecting urinary excretion of bone minerals. Int J Food Sci Nutr. 2008 Jun;59(4):347-55.
Schoppen S, Sánchez-Muniz FJ, Pérez-Granados M, Gómez-Gerique JA, Sarriá B, Navas-Carretero S, Pilar Vaquero M. Does bicarbonated mineral water rich in sodium change insulin sensitivity of postmenopausal women? Nutr Hosp. 2007 Sep-Oct;22(5):538-44.
Pérez-Granados AM, Navas-Carretero S, Schoppen S, Vaquero MP. Reduction in cardiovascular risk by sodium-bicarbonated mineral water in moderately hypercholesterolemic young adults. J Nutr Biochem. 2010 Oct;21(10):948-53. doi: 10.1016/j.jnutbio.2009.07.010. Epub 2009 Dec 1.
Schoppen S, Pérez-Granados AM, Navas-Carretero S, Vaquero MP. Postprandial lipaemia and endothelial adhesion molecules in pre- and postmenopausal Spanish women. Nutr Hosp. 2010 Mar-Apr;25(2):256-61.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M Pilar Vaquero, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01334840     History of Changes
Other Study ID Numbers: BW-09
First Submitted: April 12, 2011
First Posted: April 13, 2011
Last Update Posted: July 30, 2014
Last Verified: April 2011

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


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