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Cardiovascular DiseasesNCT01334840

Mechanism of Action of Vichy Catalan Water

A study testing Bicarbonated mineral water in people with Cardiovascular Diseases, run by National Research Council, Spain at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Bicarbonated mineral water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteSpain
Study dates
Nov 2009to Jul 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adult (>18 and <40 years)
  • BMI >18 and <30 kg/m2

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)

    Madrid, Madrid, 28040

Other trials in Spain

About this study

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.

Being tested
Bicarbonated mineral water, Mineral water low in mineral content (control)
Keywords
Cardiovascular risk, Cholecystokinin, Gallbladder emptying, Lipid absorption, Postprandial triacylglycerols, Sodium-bicarbonated mineral water
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bicarbonated mineral waterDietary supplement

    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)Dietary supplement

    Volunteers fasted overnight consumed:

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

Study groups in NCT01334840
Study groupRoleWhat they receive
BWExperimentalBicarbonated mineral water without meal
Receives: Dietary Supplement: Bicarbonated mineral water
BW with mealExperimentalBicarbonated mineral water with meal
Receives: Dietary Supplement: Bicarbonated mineral water
CWActive comparatorMineral water low in mineral content (control) without meal
Receives: Dietary Supplement: Mineral water low in mineral content (control)
CW with mealActive comparatorMineral water low in mineral content (control) with a meal
Receives: Dietary Supplement: Mineral water low in mineral content (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum triacylglycerols

    Measured: Baseline

  2. Serum triacylglycerols

    Measured: Postprandial 30 minutes

  3. Serum triacylglycerols

    Measured: Postprandial 60 minutes

  4. Serum triacylglycerols

    Measured: Postprandial 120 minutes

Secondary outcomes (21)

  1. Serum glucose

    Measured: Baseline

  2. Serum glucose

    Measured: Postprandial 30 minutes

  3. Serum glucose

    Measured: Postprandial time 60 minutes

  4. Serum glucose

    Measured: Postprandial time 120 minutes

  5. Serum insulin

    Measured: Baseline

  6. Serum insulin

    Measured: Postprandial 30 minutes

  7. Serum insulin

    Measured: Postprandial 60 minutes

  8. Serum insulin

    Measured: Postprandial 120 minutes

  9. Cholecystokinin

    Measured: Baseline

  10. Cholecystokinin

    Measured: Postprandial 30 minutes

  11. Cholecystokinin

    Measured: Postprandial 60 minutes

  12. Cholecystokinin

    Measured: Postprandial 120 minutes

  13. Gallbladder volume

    Measured: Baseline

  14. Gallbladder volume

    Measured: Postprandial 15 minutes

  15. Gallbladder volume

    Measured: Postprandial 30 minutes

  16. Gallbladder volume

    Measured: Postprandial 60 minutes

  17. Gallbladder volume

    Measured: Postprandial 120 minutes

  18. Aldosterone

    Measured: Baseline

  19. Aldosterone

    Measured: Postprandial 30 minutes

  20. Aldosterone

    Measured: Postprandial 60 minutes

  21. Aldosterone

    Measured: Postprandial 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2011 (estimated)
  2. Study startNov 2009
  3. Primary completionMay 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334840
Sponsor's protocol ID
BW-09
Status last verified
Apr 2011
First submitted
12 Apr 2011
Last updated
30 Jul 2014
Results posted
No

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.

    PubMed 15113945

  • 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.

    PubMed 15877873

  • 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.

    PubMed 16197584

  • 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.

    PubMed 17886090

  • 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.

    PubMed 17970536

  • 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.

    PubMed 19954956

  • 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.

    PubMed 20449535

  • 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.

    PubMed 21913027

  • 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.

    PubMed 27356528

Questions about this trial

What is this clinical trial studying?

A study testing Bicarbonated mineral water in people with Cardiovascular Diseases, run by National Research Council, Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum triacylglycerols (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334840, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.

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