HypertriglyceridemiaNCT01819636
Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile
A study testing sparkling highly mineral bicarbonated sodium water in people with Hypertriglyceridemia, run by Neptune at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- sparkling highly mineral bicarbonated sodium water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
OPTIMED
Gières, 38610
Naturalpha
Lille, 59020
Biofortis
Saint-Herblain, 44800
About this study
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- sparkling highly mineral bicarbonated sodium water
- Keywords
- Blood triglyceride, Bicarbonated mineral wate, Post-prandial triglyceridemia, lipid metabolism, Cardiovascular risk
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sparkling highly mineral bicarbonated sodium waterOther
1,25 liter a day at the mealtimes
| Study group | Role | What they receive |
|---|---|---|
| Sparkling highly mineral bicarbonated sodium water | Experimental | 1.25 liter a day of sparkling highly mineral bicarbonated sodium water Receives: Other: sparkling highly mineral bicarbonated sodium water |
| Sparkling low mineralized water | Placebo comparator | 1.25 liter a day of sparkling low mineralized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma triglyceride
Measured: 4 weeks
Secondary outcomes (34)
Fasting plasma total cholesterol
Measured: 4 and 8 weeks
Fasting plasma triglyceride
Measured: 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides
Measured: 0 and 8 weeks
Fasting plasma High Density Lipoprotein cholesterol
Measured: 4 and 8 weeks
Fasting plasma Low Density Lipoprotein cholesterol
Measured: 4 and 8 weeks
Fasting plasma glucose
Measured: 4 and 8 weeks
Heart rate
Measured: 4 and 8 weeks
Systolic Blood Pressure
Measured: 4 and 8 weeks
Diastolic Blood Pressure
Measured: 4 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol
Measured: 0 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Cmax between T0 and T480min of plasma triglyceride
Measured: 0 and 8 weeks
Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Cmax between T0 and T480min of plasma total cholesterol
Measured: 0 and 8 weeks
Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Delta peak between T0 and T480min of plasma total cholesterol
Measured: 0 and 8 weeks
Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol
Measured: 0 and 8 weeks
Kinetic between T0 and T480min of plasma total cholesterol
Measured: 0 and 8 weeks
Kinetic between T0 and T480min of plasma triglycerides
Measured: 0 and 8 weeks
Delta peak between T0 and T480min of plasma triglycerides
Measured: 0 and 8 weeks
Alanine Amino Transferase
Measured: 4 and 8 weeks
Aspartate Amino Transferase
Measured: 4 and 8 weeks
Plasmatic urea
Measured: 4 and 8 weeks
Plasmatic creatinine
Measured: 4 and 8 weeks
Plasmatic potassium
Measured: 4 and 8 weeks
Plasmatic sodium
Measured: 4 and 8 weeks
Plasmatic Chloride
Measured: 4 and 8 weeks
Gamma Glutamyl Transferase
Measured: 8 weeks
Bilirubin
Measured: 8 weeks
Complete blood count
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neptune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gendre, PhD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819636
- Sponsor's protocol ID
- LIPO-2
- Other IDs
- 2012-A01645-38
- Status last verified
- Jul 2014
- First submitted
- 18 Mar 2013
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile
- ClinicalTrials.gov ID
- NCT01819636
- Acronym / sponsor ID
- LIPO-2
- Conditions
- Hypertriglyceridemia
- Keywords
- Blood triglyceride, Bicarbonated mineral wate, Post-prandial triglyceridemia, lipid metabolism, Cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- NeptuneIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sparkling highly mineral bicarbonated sodium water | Experimental | Other: sparkling highly mineral bicarbonated sodium water1.25 liter a day of sparkling highly mineral bicarbonated sodium water |
| Sparkling low mineralized water | Placebo comparator | –1.25 liter a day of sparkling low mineralized water |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sparkling highly mineral bicarbonated sodium water1,25 liter a day at the mealtimes | Other | Sparkling highly mineral bicarbonated sodium water |
Primary outcome
Fasting plasma triglyceride
Time frame: 4 weeks
34 secondary outcomes
Fasting plasma total cholesterol
Time frame: 4 and 8 weeks
Fasting plasma triglyceride
Time frame: 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides
Time frame: 0 and 8 weeks
Fasting plasma High Density Lipoprotein cholesterol
Time frame: 4 and 8 weeks
Fasting plasma Low Density Lipoprotein cholesterol
Time frame: 4 and 8 weeks
Fasting plasma glucose
Time frame: 4 and 8 weeks
Heart rate
Time frame: 4 and 8 weeks
Systolic Blood Pressure
Time frame: 4 and 8 weeks
Diastolic Blood Pressure
Time frame: 4 and 8 weeks
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol
Time frame: 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
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Cmax between T0 and T480min of plasma triglyceride
Time frame: 0 and 8 weeks
Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Cmax between T0 and T480min of plasma total cholesterol
Time frame: 0 and 8 weeks
Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Delta peak between T0 and T480min of plasma total cholesterol
Time frame: 0 and 8 weeks
Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time frame: 0 and 8 weeks
Kinetic between T0 and T480min of plasma total cholesterol
Time frame: 0 and 8 weeks
Kinetic between T0 and T480min of plasma triglycerides
Time frame: 0 and 8 weeks
Delta peak between T0 and T480min of plasma triglycerides
Time frame: 0 and 8 weeks
Alanine Amino Transferase
Time frame: 4 and 8 weeks
Aspartate Amino Transferase
Time frame: 4 and 8 weeks
Plasmatic urea
Time frame: 4 and 8 weeks
Plasmatic creatinine
Time frame: 4 and 8 weeks
Plasmatic potassium
Time frame: 4 and 8 weeks
Plasmatic sodium
Time frame: 4 and 8 weeks
Plasmatic Chloride
Time frame: 4 and 8 weeks
Gamma Glutamyl Transferase
Time frame: 8 weeks
Bilirubin
Time frame: 8 weeks
Complete blood count
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gendre, PhD principal investigator
BioFortis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sparkling highly mineral bicarbonated sodium water in people with Hypertriglyceridemia, run by Neptune at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma triglyceride (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.