NCT01334840

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
Last Updated

July 30, 2014

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

April 12, 2011

Last Update Submit

July 29, 2014

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular riskCholecystokininGallbladder emptyingLipid absorptionPostprandial triacylglycerolsSodium-bicarbonated mineral water

Outcome Measures

Primary Outcomes (4)

  • Serum triacylglycerols

    Baseline

  • Serum triacylglycerols

    Postprandial 30 minutes

  • Serum triacylglycerols

    Postprandial 60 minutes

  • Serum triacylglycerols

    Postprandial 120 minutes

Secondary Outcomes (21)

  • Serum glucose

    Baseline

  • Serum glucose

    Postprandial 30 minutes

  • Serum glucose

    Postprandial time 60 minutes

  • Serum glucose

    Postprandial time 120 minutes

  • Serum insulin

    Baseline

  • +16 more secondary outcomes

Study Arms (4)

BW

EXPERIMENTAL

Bicarbonated mineral water without meal

Dietary Supplement: Bicarbonated mineral water

BW with meal

EXPERIMENTAL

Bicarbonated mineral water with meal

Dietary Supplement: Bicarbonated mineral water

CW

ACTIVE COMPARATOR

Mineral water low in mineral content (control) without meal

Dietary Supplement: Mineral water low in mineral content (control)

CW with meal

ACTIVE COMPARATOR

Mineral water low in mineral content (control) with a meal

Dietary Supplement: Mineral water low in mineral content (control)

Interventions

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

BWBW 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

CWCW with meal

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madrid, Madrid, 28040, Spain

Location

Related Publications (11)

  • 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.

    PMID: 15113945BACKGROUND

  • 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.

    PMID: 15877873BACKGROUND

  • 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.

    PMID: 16197584BACKGROUND

  • 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.

    PMID: 17886090BACKGROUND

  • 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.

    PMID: 17970536BACKGROUND

  • 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.

    PMID: 19954956BACKGROUND

  • 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.

    PMID: 20449535BACKGROUND

  • 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.

    PMID: 21913027RESULT

  • 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

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 27356528DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • M Pilar Vaquero, Dr

    National Research Council, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 13, 2011

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

July 1, 2010

Last Updated

July 30, 2014

Record last verified: 2011-04

Locations

ES(1)