Mechanism of Action of Vichy Catalan Water

Cardiovascular Diseases Clinical Trial

Official title:

Mechanism of Action of Vichy Catalan Water

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334840
• Other study ID #: BW-09
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: July 29, 2014
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2011
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Vichy Catalán, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. E — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum triacylglycerols		Baseline	No
Primary	Serum triacylglycerols		Postprandial 30 minutes	No
Primary	Serum triacylglycerols		Postprandial 60 minutes	No
Primary	Serum triacylglycerols		Postprandial 120 minutes	No
Secondary	Serum glucose		Baseline	No
Secondary	Serum glucose		Postprandial 30 minutes	No
Secondary	Serum glucose		Postprandial time 60 minutes	No
Secondary	Serum glucose		Postprandial time 120 minutes	No
Secondary	Serum insulin		Baseline	No
Secondary	Serum insulin		Postprandial 30 minutes	No
Secondary	Serum insulin		Postprandial 60 minutes	No
Secondary	Serum insulin		Postprandial 120 minutes	No
Secondary	Cholecystokinin		Baseline	No
Secondary	Cholecystokinin		Postprandial 30 minutes	No
Secondary	Cholecystokinin		Postprandial 60 minutes	No
Secondary	Cholecystokinin		Postprandial 120 minutes	No
Secondary	Gallbladder volume		Baseline	No
Secondary	Gallbladder volume		Postprandial 15 minutes	No
Secondary	Gallbladder volume		Postprandial 30 minutes	No
Secondary	Gallbladder volume		Postprandial 60 minutes	No
Secondary	Gallbladder volume		Postprandial 120 minutes	No
Secondary	Aldosterone		Baseline	No
Secondary	Aldosterone		Postprandial 30 minutes	No
Secondary	Aldosterone		Postprandial 60 minutes	No
Secondary	Aldosterone		Postprandial 120 minutes	No