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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sparkling highly mineral bicarbonated sodium water
Sponsored by
Neptune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertriglyceridemia focused on measuring Blood triglyceride, Bicarbonated mineral wate, Post-prandial triglyceridemia, lipid metabolism, Cardiovascular risk

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OPTIMED
  • Naturalpha
  • Biofortis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sparkling highly mineral bicarbonated sodium water

Sparkling low mineralized water

Arm Description

1.25 liter a day of sparkling highly mineral bicarbonated sodium water

1.25 liter a day of sparkling low mineralized water

Outcomes

Primary Outcome Measures

Fasting plasma triglyceride

Secondary Outcome Measures

Fasting plasma total cholesterol
Fasting plasma triglyceride
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides
Fasting plasma High Density Lipoprotein cholesterol
Fasting plasma Low Density Lipoprotein cholesterol
Fasting plasma glucose
Heart rate
Systolic Blood Pressure
Diastolic Blood Pressure
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Cmax between T0 and T480min of plasma triglyceride
Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol
Cmax between T0 and T480min of plasma total cholesterol
Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol
Delta peak between T0 and T480min of plasma total cholesterol
Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol
Kinetic between T0 and T480min of plasma total cholesterol
Kinetic between T0 and T480min of plasma triglycerides
Delta peak between T0 and T480min of plasma triglycerides
Alanine Amino Transferase
Aspartate Amino Transferase
Plasmatic urea
Plasmatic creatinine
Plasmatic potassium
Plasmatic sodium
Plasmatic Chloride
Gamma Glutamyl Transferase
Bilirubin
Complete blood count

Full Information

First Posted
March 18, 2013
Last Updated
July 28, 2014
Sponsor
Neptune
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1. Study Identification

Unique Protocol Identification Number
NCT01819636
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neptune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
Blood triglyceride, Bicarbonated mineral wate, Post-prandial triglyceridemia, lipid metabolism, Cardiovascular risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sparkling highly mineral bicarbonated sodium water
Arm Type
Experimental
Arm Description
1.25 liter a day of sparkling highly mineral bicarbonated sodium water
Arm Title
Sparkling low mineralized water
Arm Type
Placebo Comparator
Arm Description
1.25 liter a day of sparkling low mineralized water
Intervention Type
Other
Intervention Name(s)
sparkling highly mineral bicarbonated sodium water
Intervention Description
1,25 liter a day at the mealtimes
Primary Outcome Measure Information:
Title
Fasting plasma triglyceride
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fasting plasma total cholesterol
Time Frame
4 and 8 weeks
Title
Fasting plasma triglyceride
Time Frame
8 weeks
Title
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides
Time Frame
0 and 8 weeks
Title
Fasting plasma High Density Lipoprotein cholesterol
Time Frame
4 and 8 weeks
Title
Fasting plasma Low Density Lipoprotein cholesterol
Time Frame
4 and 8 weeks
Title
Fasting plasma glucose
Time Frame
4 and 8 weeks
Title
Heart rate
Time Frame
4 and 8 weeks
Title
Systolic Blood Pressure
Time Frame
4 and 8 weeks
Title
Diastolic Blood Pressure
Time Frame
4 and 8 weeks
Title
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol
Time Frame
0 and 8 weeks
Title
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Cmax between T0 and T480min of plasma triglyceride
Time Frame
0 and 8 weeks
Title
Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Cmax between T0 and T480min of plasma total cholesterol
Time Frame
0 and 8 weeks
Title
Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Delta peak between T0 and T480min of plasma total cholesterol
Time Frame
0 and 8 weeks
Title
Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol
Time Frame
0 and 8 weeks
Title
Kinetic between T0 and T480min of plasma total cholesterol
Time Frame
0 and 8 weeks
Title
Kinetic between T0 and T480min of plasma triglycerides
Time Frame
0 and 8 weeks
Title
Delta peak between T0 and T480min of plasma triglycerides
Time Frame
0 and 8 weeks
Title
Alanine Amino Transferase
Time Frame
4 and 8 weeks
Title
Aspartate Amino Transferase
Time Frame
4 and 8 weeks
Title
Plasmatic urea
Time Frame
4 and 8 weeks
Title
Plasmatic creatinine
Time Frame
4 and 8 weeks
Title
Plasmatic potassium
Time Frame
4 and 8 weeks
Title
Plasmatic sodium
Time Frame
4 and 8 weeks
Title
Plasmatic Chloride
Time Frame
4 and 8 weeks
Title
Gamma Glutamyl Transferase
Time Frame
8 weeks
Title
Bilirubin
Time Frame
8 weeks
Title
Complete blood count
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
PCSK9 protein
Time Frame
4 and 8 weeks
Title
High Density Lipoprotein cholesterol efflux
Time Frame
4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gendre, PhD
Organizational Affiliation
BioFortis
Official's Role
Principal Investigator
Facility Information:
Facility Name
OPTIMED
City
Gières
ZIP/Postal Code
38610
Country
France
Facility Name
Naturalpha
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Biofortis
City
Saint Herblain
ZIP/Postal Code
44800
Country
France

12. IPD Sharing Statement

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

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