World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01334840
Date of registration: 12/04/2011
Primary sponsor: National Research Council, Spain
Public title: Mechanism of Action of Vichy Catalan Water
Scientific title: Mechanism of Action of Vichy Catalan Water
Date of first enrolment: November 2009
Target sample size: 21
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01334840
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
Spain
Contacts
Name:   M Pilar Vaquero, Dr
Address: 
Telephone:
Email:
Affiliation:  National Research Council, Spain
Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Cardiovascular Diseases
Intervention(s)
Dietary Supplement: Bicarbonated mineral water
Dietary Supplement: Mineral water low in mineral content (control)
Primary Outcome(s)
Serum triacylglycerols [Time Frame: Baseline]
Serum triacylglycerols [Time Frame: Postprandial 120 minutes]
Serum triacylglycerols [Time Frame: Postprandial 30 minutes]
Serum triacylglycerols [Time Frame: Postprandial 60 minutes]
Secondary Outcome(s)
Cholecystokinin [Time Frame: Baseline]
Cholecystokinin [Time Frame: Postprandial 120 minutes]
Cholecystokinin [Time Frame: Postprandial 30 minutes]
Cholecystokinin [Time Frame: Postprandial 60 minutes]
Gallbladder volume [Time Frame: Baseline]
Gallbladder volume [Time Frame: Postprandial 120 minutes]
Gallbladder volume [Time Frame: Postprandial 15 minutes]
Gallbladder volume [Time Frame: Postprandial 30 minutes]
Gallbladder volume [Time Frame: Postprandial 60 minutes]
Serum glucose [Time Frame: Baseline]
Serum glucose [Time Frame: Postprandial 30 minutes]
Serum glucose [Time Frame: Postprandial time 120 minutes]
Serum glucose [Time Frame: Postprandial time 60 minutes]
Serum insulin [Time Frame: Baseline]
Serum insulin [Time Frame: Postprandial 120 minutes]
Serum insulin [Time Frame: Postprandial 30 minutes]
Serum insulin [Time Frame: Postprandial 60 minutes]
Secondary ID(s)
BW-09
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Vichy Catalán, Spain
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history