Clinical trial NCT01819636: Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile
Official title: Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: Blood triglyceride
Bicarbonated mineral wate
Post-prandial triglyceridemia
lipid metabolism
Cardiovascular risk
Lead sponsor: Neptune
Sponsor class: INDUSTRY
First posted: 2013-03-27
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Fasting plasma triglyceride
timeFrame: 4 weeks
Secondary outcomes:
measure: Fasting plasma total cholesterol
timeFrame: 4 and 8 weeks
measure: Fasting plasma triglyceride
timeFrame: 8 weeks
measure: Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides
timeFrame: 0 and 8 weeks
measure: Fasting plasma High Density Lipoprotein cholesterol
timeFrame: 4 and 8 weeks
measure: Fasting plasma Low Density Lipoprotein cholesterol
timeFrame: 4 and 8 weeks
measure: Fasting plasma glucose
timeFrame: 4 and 8 weeks
measure: Heart rate
timeFrame: 4 and 8 weeks
measure: Systolic Blood Pressure
timeFrame: 4 and 8 weeks
measure: Diastolic Blood Pressure
timeFrame: 4 and 8 weeks
measure: Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol
timeFrame: 0 and 8 weeks
measure: Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Cmax between T0 and T480min of plasma triglyceride
timeFrame: 0 and 8 weeks
measure: Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Cmax between T0 and T480min of plasma total cholesterol
timeFrame: 0 and 8 weeks
measure: Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Delta peak between T0 and T480min of plasma total cholesterol
timeFrame: 0 and 8 weeks
measure: Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol
timeFrame: 0 and 8 weeks
measure: Kinetic between T0 and T480min of plasma total cholesterol
timeFrame: 0 and 8 weeks
measure: Kinetic between T0 and T480min of plasma triglycerides
timeFrame: 0 and 8 weeks
measure: Delta peak between T0 and T480min of plasma triglycerides
timeFrame: 0 and 8 weeks
measure: Alanine Amino Transferase
timeFrame: 4 and 8 weeks
measure: Aspartate Amino Transferase
timeFrame: 4 and 8 weeks
measure: Plasmatic urea
timeFrame: 4 and 8 weeks
measure: Plasmatic creatinine
timeFrame: 4 and 8 weeks
measure: Plasmatic potassium
timeFrame: 4 and 8 weeks
measure: Plasmatic sodium
timeFrame: 4 and 8 weeks
measure: Plasmatic Chloride
timeFrame: 4 and 8 weeks
measure: Gamma Glutamyl Transferase
timeFrame: 8 weeks
measure: Bilirubin
timeFrame: 8 weeks
measure: Complete blood count
timeFrame: 8 weeks
Other outcomes:
measure: PCSK9 protein
timeFrame: 4 and 8 weeks
measure: High Density Lipoprotein cholesterol efflux
timeFrame: 4 and 8 weeks
Locations:
city: Gières
country: France
facility: OPTIMED
city: Lille
country: France
facility: Naturalpha
city: Saint Herblain
country: France
facility: Biofortis
Study officials:
affiliation: BioFortis
name: David Gendre, PhD
role: PRINCIPAL_INVESTIGATOR
References: