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

July 28, 2014 updated by: Neptune
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France, 38610
        • Optimed
      • Lille, France, 59020
        • Naturalpha
      • Saint Herblain, France, 44800
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Fasting plasma triglyceride
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Bilirubin
Time Frame: 8 weeks
8 weeks
Fasting plasma total cholesterol
Time Frame: 4 and 8 weeks
4 and 8 weeks
Fasting plasma triglyceride
Time Frame: 8 weeks
8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides
Time Frame: 0 and 8 weeks
0 and 8 weeks
Fasting plasma High Density Lipoprotein cholesterol
Time Frame: 4 and 8 weeks
4 and 8 weeks
Fasting plasma Low Density Lipoprotein cholesterol
Time Frame: 4 and 8 weeks
4 and 8 weeks
Fasting plasma glucose
Time Frame: 4 and 8 weeks
4 and 8 weeks
Heart rate
Time Frame: 4 and 8 weeks
4 and 8 weeks
Systolic Blood Pressure
Time Frame: 4 and 8 weeks
4 and 8 weeks
Diastolic Blood Pressure
Time Frame: 4 and 8 weeks
4 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Cmax between T0 and T480min of plasma triglyceride
Time Frame: 0 and 8 weeks
0 and 8 weeks
Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Cmax between T0 and T480min of plasma total cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Delta peak between T0 and T480min of plasma total cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Kinetic between T0 and T480min of plasma total cholesterol
Time Frame: 0 and 8 weeks
0 and 8 weeks
Kinetic between T0 and T480min of plasma triglycerides
Time Frame: 0 and 8 weeks
0 and 8 weeks
Delta peak between T0 and T480min of plasma triglycerides
Time Frame: 0 and 8 weeks
0 and 8 weeks
Alanine Amino Transferase
Time Frame: 4 and 8 weeks
4 and 8 weeks
Aspartate Amino Transferase
Time Frame: 4 and 8 weeks
4 and 8 weeks
Plasmatic urea
Time Frame: 4 and 8 weeks
4 and 8 weeks
Plasmatic creatinine
Time Frame: 4 and 8 weeks
4 and 8 weeks
Plasmatic potassium
Time Frame: 4 and 8 weeks
4 and 8 weeks
Plasmatic sodium
Time Frame: 4 and 8 weeks
4 and 8 weeks
Plasmatic Chloride
Time Frame: 4 and 8 weeks
4 and 8 weeks
Gamma Glutamyl Transferase
Time Frame: 8 weeks
8 weeks
Complete blood count
Time Frame: 8 weeks
8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
PCSK9 protein
Time Frame: 4 and 8 weeks
4 and 8 weeks
High Density Lipoprotein cholesterol efflux
Time Frame: 4 and 8 weeks
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neptune

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Gendre, PhD, Biofortis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LiPO-2
  • 2012-A01645-38 (REGISTRY: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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