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Mechanism of Action of Vichy Catalan Water

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334840
First Posted: April 13, 2011
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vichy Catalán, Spain
Information provided by:
National Research Council, Spain
April 12, 2011
April 13, 2011
July 30, 2014
November 2009
May 2010   (Final data collection date for primary outcome measure)
  • Serum triacylglycerols [ Time Frame: Baseline ]
  • Serum triacylglycerols [ Time Frame: Postprandial 30 minutes ]
  • Serum triacylglycerols [ Time Frame: Postprandial 60 minutes ]
  • Serum triacylglycerols [ Time Frame: Postprandial 120 minutes ]
Same as current
Complete list of historical versions of study NCT01334840 on ClinicalTrials.gov Archive Site
  • Serum glucose [ Time Frame: Baseline ]
  • Serum glucose [ Time Frame: Postprandial 30 minutes ]
  • Serum glucose [ Time Frame: Postprandial time 60 minutes ]
  • Serum glucose [ Time Frame: Postprandial time 120 minutes ]
  • Serum insulin [ Time Frame: Baseline ]
  • Serum insulin [ Time Frame: Postprandial 30 minutes ]
  • Serum insulin [ Time Frame: Postprandial 60 minutes ]
  • Serum insulin [ Time Frame: Postprandial 120 minutes ]
  • Cholecystokinin [ Time Frame: Baseline ]
  • Cholecystokinin [ Time Frame: Postprandial 30 minutes ]
  • Cholecystokinin [ Time Frame: Postprandial 60 minutes ]
  • Cholecystokinin [ Time Frame: Postprandial 120 minutes ]
  • Gallbladder volume [ Time Frame: Baseline ]
  • Gallbladder volume [ Time Frame: Postprandial 15 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 30 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 60 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 120 minutes ]
  • Aldosterone [ Time Frame: Baseline ]
  • Aldosterone [ Time Frame: Postprandial 30 minutes ]
  • Aldosterone [ Time Frame: Postprandial 60 minutes ]
  • Aldosterone [ Time Frame: Postprandial 120 minutes ]
  • Serum glucose [ Time Frame: Baseline ]
  • Serum glucose [ Time Frame: Postprandial 30 minutes ]
  • Serum glucose [ Time Frame: Postprandial time 60 minutes ]
  • Serum glucose [ Time Frame: Postprandial time 120 minutes ]
  • Serum insulin [ Time Frame: Baseline ]
  • Serum insulin [ Time Frame: Postprandial 30 minutes ]
  • Serum insulin [ Time Frame: Postprandial 60 minutes ]
  • Serum insulin [ Time Frame: Postprandial 120 minutes ]
  • Cholecystokinin [ Time Frame: Baseline ]
  • Cholecystokinin [ Time Frame: Postprandial 30 minutes ]
  • Cholecystokinin [ Time Frame: Postprandial 60 minutes ]
  • Cholecystokinin [ Time Frame: Postprandial 120 minutes ]
  • Gallbladder volume [ Time Frame: Baseline ]
  • Gallbladder volume [ Time Frame: Postprandial 15 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 30 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 60 minutes ]
  • Gallbladder volume [ Time Frame: Postprandial 120 minutes ]
Not Provided
Not Provided
 
Mechanism of Action of Vichy Catalan Water
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Diseases
  • 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

  • Dietary Supplement: 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

  • Experimental: BW
    Bicarbonated mineral water without meal
    Intervention: Dietary Supplement: Bicarbonated mineral water
  • Experimental: BW with meal
    Bicarbonated mineral water with meal
    Intervention: Dietary Supplement: Bicarbonated mineral water
  • Active Comparator: CW
    Mineral water low in mineral content (control) without meal
    Intervention: Dietary Supplement: Mineral water low in mineral content (control)
  • Active Comparator: CW with meal
    Mineral water low in mineral content (control) with a meal
    Intervention: Dietary Supplement: Mineral water low in mineral content (control)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2010
May 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01334840
BW-09
Not Provided
Not Provided
Not Provided
M Pilar Vaquero, National Research Council, Spain
National Research Council, Spain
Vichy Catalán, Spain
Principal Investigator: M Pilar Vaquero, Dr National Research Council, Spain
National Research Council, Spain
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP