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Completed

NCT Number: NCT01334840

Mechanism of Action of Vichy Catalan Water

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bicarbonated mineral water

Dietary 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

Primary outcomes

  1. Serum triacylglycerols

    Time frame: Baseline

  2. Serum triacylglycerols

    Time frame: Postprandial 30 minutes

  3. Serum triacylglycerols

    Time frame: Postprandial 60 minutes

  4. Serum triacylglycerols

    Time frame: Postprandial 120 minutes

Secondary outcomes

  1. Serum glucose

    Time frame: Baseline

  2. Serum glucose

    Time frame: Postprandial 30 minutes

  3. Serum glucose

    Time frame: Postprandial time 60 minutes

  4. Serum glucose

    Time frame: Postprandial time 120 minutes

  5. Serum insulin

    Time frame: Baseline

  6. Serum insulin

    Time frame: Postprandial 30 minutes

  7. Serum insulin

    Time frame: Postprandial 60 minutes

  8. Serum insulin

    Time frame: Postprandial 120 minutes

  9. Cholecystokinin

    Time frame: Baseline

  10. Cholecystokinin

    Time frame: Postprandial 30 minutes

  11. Cholecystokinin

    Time frame: Postprandial 60 minutes

  12. Cholecystokinin

    Time frame: Postprandial 120 minutes

  13. Gallbladder volume

    Time frame: Baseline

  14. Gallbladder volume

    Time frame: Postprandial 15 minutes

  15. Gallbladder volume

    Time frame: Postprandial 30 minutes

  16. Gallbladder volume

    Time frame: Postprandial 60 minutes

  17. Gallbladder volume

    Time frame: Postprandial 120 minutes

  18. Aldosterone

    Time frame: Baseline

  19. Aldosterone

    Time frame: Postprandial 30 minutes

  20. Aldosterone

    Time frame: Postprandial 60 minutes

  21. Aldosterone

    Time frame: Postprandial 120 minutes

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Vichy Catalán, Spain

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2011
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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