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

NCT ID: NCT01819636

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Sparkling highly mineral bicarbonated sodium water

1.25 liter a day of sparkling highly mineral bicarbonated sodium water

Group Type: EXPERIMENTAL

sparkling highly mineral bicarbonated sodium water

Intervention Type: OTHER

1,25 liter a day at the mealtimes

Sparkling low mineralized water

1.25 liter a day of sparkling low mineralized water

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

sparkling highly mineral bicarbonated sodium water

1,25 liter a day at the mealtimes

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neptune

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Gendre, PhD

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Locations

OPTIMED

Gières, , France

Naturalpha

Lille, , France

Biofortis

Saint-Herblain, , France

Countries

France

Other Identifiers

2012-A01645-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

LIPO-2

Identifier Type: -

Identifier Source: org_study_id