Clinical trial NCT01334840: Mechanism of Action of Vichy Catalan Water
Official title: Mechanism of Action of Vichy Catalan Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular risk
Cholecystokinin
Gallbladder emptying
Lipid absorption
Postprandial triacylglycerols
Sodium-bicarbonated mineral water
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Vichy Catalán, Spain
First posted: 2011-04-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Serum triacylglycerols
timeFrame: Baseline
measure: Serum triacylglycerols
timeFrame: Postprandial 30 minutes
measure: Serum triacylglycerols
timeFrame: Postprandial 60 minutes
measure: Serum triacylglycerols
timeFrame: Postprandial 120 minutes
Secondary outcomes:
measure: Serum glucose
timeFrame: Baseline
measure: Serum glucose
timeFrame: Postprandial 30 minutes
measure: Serum glucose
timeFrame: Postprandial time 60 minutes
measure: Serum glucose
timeFrame: Postprandial time 120 minutes
measure: Serum insulin
timeFrame: Baseline
measure: Serum insulin
timeFrame: Postprandial 30 minutes
measure: Serum insulin
timeFrame: Postprandial 60 minutes
measure: Serum insulin
timeFrame: Postprandial 120 minutes
measure: Cholecystokinin
timeFrame: Baseline
measure: Cholecystokinin
timeFrame: Postprandial 30 minutes
measure: Cholecystokinin
timeFrame: Postprandial 60 minutes
measure: Cholecystokinin
timeFrame: Postprandial 120 minutes
measure: Gallbladder volume
timeFrame: Baseline
measure: Gallbladder volume
timeFrame: Postprandial 15 minutes
measure: Gallbladder volume
timeFrame: Postprandial 30 minutes
measure: Gallbladder volume
timeFrame: Postprandial 60 minutes
measure: Gallbladder volume
timeFrame: Postprandial 120 minutes
measure: Aldosterone
timeFrame: Baseline
measure: Aldosterone
timeFrame: Postprandial 30 minutes
measure: Aldosterone
timeFrame: Postprandial 60 minutes
measure: Aldosterone
timeFrame: Postprandial 120 minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)
Study officials:
affiliation: National Research Council, Spain
name: M Pilar Vaquero, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoppen S, Perez-Granados AM, Carbajal A, Oubina P, Sanchez-Muniz FJ, Gomez-Gerique JA, Vaquero MP. A sodium-rich carbonated mineral water reduces cardiovascular risk in postmenopausal women. J Nutr. 2004 May;134(5):1058-63. doi: 10.1093/jn/134.5.1058.
citation: Schoppen S, Perez-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. doi: 10.1079/bjn20041332.
citation: Schoppen S, Perez-Granados AM, Carbajal A, Sarria B, Sanchez-Muniz FJ, Gomez-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. doi: 10.1079/bjn20051515.
citation: Schoppen S, Perez-Granados AM, Carbajal A, Sarria 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. doi: 10.1080/09637480701560308.
citation: Schoppen S, Sanchez-Muniz FJ, Perez-Granados M, Gomez-Gerique JA, Sarria 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.
citation: Perez-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.
citation: Schoppen S, Perez-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.
citation: Toxqui L, Perez-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.
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
citation: 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.
citation: Toxqui L, Vaquero MP. Aldosterone changes after consumption of a sodium-bicarbonated mineral water in humans. A four-way randomized controlled trial. J Physiol Biochem. 2016 Dec;72(4):635-641. doi: 10.1007/s13105-016-0502-8. Epub 2016 Jun 29.