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Completed

NCT Number: NCT01819636

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OPTIMED, Gières, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sparkling highly mineral bicarbonated sodium water

Other

1,25 liter a day at the mealtimes

Primary outcomes

  1. Fasting plasma triglyceride

    Time frame: 4 weeks

Secondary outcomes

  1. Fasting plasma total cholesterol

    Time frame: 4 and 8 weeks

  2. Fasting plasma triglyceride

    Time frame: 8 weeks

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

    Time frame: 0 and 8 weeks

  4. Fasting plasma High Density Lipoprotein cholesterol

    Time frame: 4 and 8 weeks

  5. Fasting plasma Low Density Lipoprotein cholesterol

    Time frame: 4 and 8 weeks

  6. Fasting plasma glucose

    Time frame: 4 and 8 weeks

  7. Heart rate

    Time frame: 4 and 8 weeks

  8. Systolic Blood Pressure

    Time frame: 4 and 8 weeks

  9. Diastolic Blood Pressure

    Time frame: 4 and 8 weeks

  10. Incremental Area Under Curve (iAUC) between T0 and T480min of plasma total cholesterol

    Time frame: 0 and 8 weeks

  11. Incremental Area Under Curve (iAUC) between T0 and T480min of plasma High Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  12. Incremental Area Under Curve (iAUC) between T0 and T480min of plasma Low Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  13. Cmax between T0 and T480min of plasma triglyceride

    Time frame: 0 and 8 weeks

  14. Cmax between T0 and T480min of plasma High Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  15. Cmax between T0 and T480min of plasma total cholesterol

    Time frame: 0 and 8 weeks

  16. Cmax between T0 and T480min of plasma Low Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  17. Delta peak between T0 and T480min of plasma Low Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  18. Delta peak between T0 and T480min of plasma High Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  19. Delta peak between T0 and T480min of plasma total cholesterol

    Time frame: 0 and 8 weeks

  20. Kinetic between T0 and T480min of plasma Low Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  21. Kinetic between T0 and T480min of plasma High Density Lipoprotein cholesterol

    Time frame: 0 and 8 weeks

  22. Kinetic between T0 and T480min of plasma total cholesterol

    Time frame: 0 and 8 weeks

  23. Kinetic between T0 and T480min of plasma triglycerides

    Time frame: 0 and 8 weeks

  24. Delta peak between T0 and T480min of plasma triglycerides

    Time frame: 0 and 8 weeks

  25. Alanine Amino Transferase

    Time frame: 4 and 8 weeks

  26. Aspartate Amino Transferase

    Time frame: 4 and 8 weeks

  27. Plasmatic urea

    Time frame: 4 and 8 weeks

  28. Plasmatic creatinine

    Time frame: 4 and 8 weeks

  29. Plasmatic potassium

    Time frame: 4 and 8 weeks

  30. Plasmatic sodium

    Time frame: 4 and 8 weeks

  31. Plasmatic Chloride

    Time frame: 4 and 8 weeks

  32. Gamma Glutamyl Transferase

    Time frame: 8 weeks

  33. Bilirubin

    Time frame: 8 weeks

  34. Complete blood count

    Time frame: 8 weeks

Other outcomes

  1. PCSK9 protein

    Time frame: 4 and 8 weeks

  2. High Density Lipoprotein cholesterol efflux

    Time frame: 4 and 8 weeks

Sponsors and collaborators

Lead sponsor

Neptune

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 27, 2013
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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