NCT01819636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

March 18, 2013

Last Update Submit

July 28, 2014

Conditions

Hypertriglyceridemia

Keywords

Blood triglycerideBicarbonated mineral watePost-prandial triglyceridemialipid metabolismCardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Fasting plasma triglyceride

    4 weeks

Secondary Outcomes (34)

  • Fasting plasma total cholesterol

    4 and 8 weeks

  • Fasting plasma triglyceride

    8 weeks

  • Incremental Area Under Curve (iAUC) between T0 and T480min of plasma triglycerides

    0 and 8 weeks

  • Fasting plasma High Density Lipoprotein cholesterol

    4 and 8 weeks

  • Fasting plasma Low Density Lipoprotein cholesterol

    4 and 8 weeks

  • +29 more secondary outcomes

Other Outcomes (2)

  • PCSK9 protein

    4 and 8 weeks

  • High Density Lipoprotein cholesterol efflux

    4 and 8 weeks

Study Arms (2)

Sparkling highly mineral bicarbonated sodium water

EXPERIMENTAL

1.25 liter a day of sparkling highly mineral bicarbonated sodium water

Other: sparkling highly mineral bicarbonated sodium water

Sparkling low mineralized water

PLACEBO COMPARATOR

1.25 liter a day of sparkling low mineralized water

Interventions

sparkling highly mineral bicarbonated sodium waterOTHER

1,25 liter a day at the mealtimes

Sparkling highly mineral bicarbonated sodium water

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

OPTIMED

Gières, 38610, France

Location

Naturalpha

Lille, 59020, France

Location

Biofortis

Saint-Herblain, 44800, France

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David Gendre, PhD

    BioFortis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

FR(3)