Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

sparkling highly mineral bicarbonated sodium water

Other
Who is being recruted

Hyperlipidemias+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorNeptune
Last updated: July 29, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01819636
Principal SponsorNeptune
Last updated: July 29, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

162 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersHypertriglyceridemia

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
1.25 liter a day of sparkling highly mineral bicarbonated sodium water

Group II

Placebo
1.25 liter a day of sparkling low mineralized water

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

OPTIMED

Gières, FranceOpen OPTIMED in Google Maps

Naturalpha

Lille, France

Biofortis

Saint-Herblain, France
Completed3 Study Centers