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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819636
• Other study ID #: LIPO-2
• Secondary ID: 2012-A01645-38
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: July 28, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Neptune
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Other:
• sparkling highly mineral bicarbonated sodium water
1,25 liter a day at the mealtimes

Locations

Country	Name	City	State
France	OPTIMED	Gières
France	Naturalpha	Lille
France	Biofortis	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Neptune

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PCSK9 protein		4 and 8 weeks	No
Other	High Density Lipoprotein cholesterol efflux		4 and 8 weeks	No
Primary	Fasting plasma triglyceride		4 weeks	No
Secondary	Fasting plasma total cholesterol		4 and 8 weeks	No
Secondary	Fasting plasma triglyceride		8 weeks	No
Secondary	Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides		0 and 8 weeks	No
Secondary	Fasting plasma High Density Lipoprotein cholesterol		4 and 8 weeks	No
Secondary	Fasting plasma Low Density Lipoprotein cholesterol		4 and 8 weeks	No
Secondary	Fasting plasma glucose		4 and 8 weeks	No
Secondary	Heart rate		4 and 8 weeks	No
Secondary	Systolic Blood Pressure		4 and 8 weeks	No
Secondary	Diastolic Blood Pressure		4 and 8 weeks	No
Secondary	Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol		0 and 8 weeks	No
Secondary	Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Cmax between T0 and T480min of plasma triglyceride		0 and 8 weeks	No
Secondary	Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Cmax between T0 and T480min of plasma total cholesterol		0 and 8 weeks	No
Secondary	Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Delta peak between T0 and T480min of plasma total cholesterol		0 and 8 weeks	No
Secondary	Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol		0 and 8 weeks	No
Secondary	Kinetic between T0 and T480min of plasma total cholesterol		0 and 8 weeks	No
Secondary	Kinetic between T0 and T480min of plasma triglycerides		0 and 8 weeks	No
Secondary	Delta peak between T0 and T480min of plasma triglycerides		0 and 8 weeks	No
Secondary	Alanine Amino Transferase		4 and 8 weeks	Yes
Secondary	Aspartate Amino Transferase		4 and 8 weeks	Yes
Secondary	Plasmatic urea		4 and 8 weeks	Yes
Secondary	Plasmatic creatinine		4 and 8 weeks	Yes
Secondary	Plasmatic potassium		4 and 8 weeks	Yes
Secondary	Plasmatic sodium		4 and 8 weeks	Yes
Secondary	Plasmatic Chloride		4 and 8 weeks	Yes
Secondary	Gamma Glutamyl Transferase		8 weeks	Yes
Secondary	Bilirubin		8 weeks	Yes
Secondary	Complete blood count		8 weeks	Yes