Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neptune
ClinicalTrials.gov Identifier:
NCT01819636
First received: March 18, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

The aim of the study is to assess the beneficial effect of the short term consumption of the highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low mineralized water.


Condition Intervention
Hypertriglyceridemia
Other: sparkling highly mineral bicarbonated sodium water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

Resource links provided by NLM:


Further study details as provided by Neptune:

Primary Outcome Measures:
  • Fasting plasma triglyceride [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma total cholesterol [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma triglyceride [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma High Density Lipoprotein cholesterol [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma Low Density Lipoprotein cholesterol [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Cmax between T0 and T480min of plasma triglyceride [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Cmax between T0 and T480min of plasma total cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Delta peak between T0 and T480min of plasma total cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Kinetic between T0 and T480min of plasma total cholesterol [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Kinetic between T0 and T480min of plasma triglycerides [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Delta peak between T0 and T480min of plasma triglycerides [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • Alanine Amino Transferase [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Aspartate Amino Transferase [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Plasmatic urea [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Plasmatic creatinine [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Plasmatic potassium [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Plasmatic sodium [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Plasmatic Chloride [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Gamma Glutamyl Transferase [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Bilirubin [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Complete blood count [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • PCSK9 protein [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • High Density Lipoprotein cholesterol efflux [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: March 2013
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sparkling highly mineral bicarbonated sodium water
1.25 liter a day of sparkling highly mineral bicarbonated sodium water
Other: sparkling highly mineral bicarbonated sodium water
1,25 liter a day at the mealtimes
Placebo Comparator: Sparkling low mineralized water
1.25 liter a day of sparkling low mineralized water

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18 to 70 years (limits included) ;
  • With a BMI between 18,5 (limit excluded) and 35 kg/m² (limit excluded) ;
  • Menopausal female without hormone replacement therapy or with stable hormone replacement therapy since at least 3 months or non-menopausal female with reliable contraception since at least two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study;
  • Without changes in food habits and physical activity during the last 3 months and agreeing not to change them throughout the study
  • Tolerating sparkling mineral water consumption instead of usual water during 8 weeks
  • Fasting blood triglycerides level between 1 and 3,5 g/L (limits included);
  • Fasting total cholesterol < 3g/L;
  • Fasting blood glucose level < 1,26 g/L.

Exclusion Criteria:

  • Known or suspected food allergy or intolerance to one of the tested products' components or to related products ;
  • Consuming more than 2 alcoholic drinks daily;
  • Smoking more than 10 cigarettes daily ;
  • Following an extreme or exclusive diet (vegetarian, vegan ...)
  • With personal history of anorexia nervosa, bulimia or eating disorders;
  • With a body weight variation > 5 kg in the last 3 months;
  • Having a lifestyle deemed incompatible with the study according to the investigator;
  • With metabolic disorders such as diabetes or other chronic severe disease ;
  • Suffering from uncontrolled hypertension;
  • With severe chronic disease (cancer, HIV, renal failure, liver disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory failure, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator ;
  • Pregnant or breastfeeding women or intending to become pregnant within 4 months ahead ;
  • Under lipid-lowering therapy or stopped for less than 6 weeks for statins or fibrates and less than 6 months for niacin;
  • Eating foodstuffs or dietary supplements that may interfere with lipid metabolism (red yeast rice, policosanol, omega-3 fatty acids, plant stanol or sterol) or consuming them steadily over the last 4 weeks;
  • Using of medications which could affect lipid absorption or/and metabolism (long-term corticosteroid treatment);
  • Using a treatment which may interfere with the evolution of the parameters studied according to the investigator;
  • Who made a blood donation in the last 3 months or intending to make it within 4 months ahead ;
  • Taking part in an-other clinical trial or being in the exclusion period of a previous clinical trial.

A re-screening can occur from 2 months after the exit of study for failure to comply with the one or more of the eligibility criteria listed above.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819636

Locations
France
OPTIMED
Gières, France, 38610
Naturalpha
Lille, France, 59020
Biofortis
Saint Herblain, France, 44800
Sponsors and Collaborators
Neptune
Investigators
Principal Investigator: David Gendre, PhD BioFortis
  More Information

No publications provided

Responsible Party: Neptune
ClinicalTrials.gov Identifier: NCT01819636     History of Changes
Other Study ID Numbers: LIPO-2, 2012-A01645-38
Study First Received: March 18, 2013
Last Updated: July 28, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Neptune:
Blood triglyceride
Bicarbonated mineral wate
Post-prandial triglyceridemia
lipid metabolism
Cardiovascular risk

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 19, 2014