- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01334840
Mechanism of Action of Vichy Catalan Water
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28040
- Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: M Pilar Vaquero, Dr, National Research Council, Spain
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BW-09
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