Skip to main content
OpenTrials
Completed

NCT Number: NCT07026266

Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels

The goal of this study is to evaluate the hypolipidemic effect (reduction of Low Density Lipoprotein Cholesterol "LDL-C" values) of calcium-bicarbonate mineral water "Lete" (alkaline water, high in bicarbonate and calcium ions and low in sodium) compared to control oligomineral water "Sorgesana" on healthy volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Raffaele

Milan, Italy, 20132

About this study

This sponsored, monocentric and interventional study will consist of a screening visit, a baseline visit, a phone contact one month after the baseline visit and two follow-up visits in person, two and four months after the baseline visit. After signing the informed consent and verifying the eligibility criteria, 160 healthy subjects will be randomized in a 1:1 double-blind ratio to one of two study arms. During the baseline visit, informations regarding the patient's medical history, demographic, anthropometric and blood pressure data and concomitant medications will be collected and the patient will be asked to complete a questionnaire related to physical activity assessment and to undergo an evaluation test for proper nutrition. Then, a blood sample will be taken for hematochemical analysis to evaluate the study endpoints. Finally, during the two follow-up visits, treatment adherence will be assessed, a blood sample will be taken for hematochemical analysis and the patient will be asked to complete the questionnaire and to undergo the evaluation test for proper nutrition. Additionally, at the second follow-up visit, anthropometric and blood pressure data will be collected

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy subjects
  • age 18-60 years
  • LDL-C values > 116 mg/dl
  • not already being treated with cholesterol-lowering medications (e.g. statins, ezetimibe, monoclonal antibodies, bempedoic acid) and/or supplements (e.g. fermented red rice, coenzyme Q, folic acid, berberine, vitamin E, polyphenols from olive oil, etc.)

Exclusion criteria

  • BMI < 20 and > 30 kg/m2
  • diabetes mellitus
  • arterial hypertension
  • gastrointestinal (e.g. gastro-duodenal ulcer, ulcerative colitis, diverticulosis of the colon, etc.), liver or renal diseases
  • familial hypercholesterolemia
  • treatment with drugs that could influence lipid metabolism (estrogen replacement hormone therapy, corticosteroid therapy, insulin therapy)
  • Consumers of fortified foods that could influence lipid metabolism (containing n-3 fatty acids or phytosterols)

Treatment and study plan

Water

Other

Calcium-bicarbonate mineral water "Lete"

Primary outcomes

  1. Variation of LDL-C values after four months of treatment

    Time frame: Four months

    Variation of LDL-C values (in mg/dl) after four months of treatment with the calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

Secondary outcomes

  1. Variation of the anthropometric data of weight after two and four months of treatment

    Time frame: Four months

    Variation of the anthropometric data of weight (in kg) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  2. Variation of the anthropometric data of Body Mass Index "BMI" after two and four months of treatment

    Time frame: Four months

    Variation of the anthropometric data of BMI (in kg/m^2) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  3. Variation of the anthropometric data of abdominal circumference after two and four months of treatment

    Time frame: Four months

    Variation of the anthropometric data of abdominal circumference (in cm) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  4. Variation of blood pressure values after two and four months of treatment

    Time frame: Four months

    Variation of blood pressure values (in mmHg) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  5. Variation of heart rate after two and four months of treatment

    Time frame: Four months

    Variation of heart rate (in bpm) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  6. Variation of LDL-C values after two and four months of treatment

    Time frame: Four months

    Variation of LDL-C values (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  7. Variation of the parameters of total cholesterol after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of total cholesterol (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  8. Variation of the parameters of High Density Lipoprotein "HDL" cholesterol after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of HDL cholesterol (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  9. Variation of the parameters of triglycerides after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of triglycerides (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  10. Variation of the parameters of Lipoprotein a "Lp(a)" after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of Lp(a) (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  11. Variation of the parameters of Apolipoprotein B-100 after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of Apolipoprotein B-100 (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  12. Variation of the parameters of Apolipoprotein A1 after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of Apolipoprotein A1 (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  13. Variation of the parameters of creatinine after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of creatinine (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  14. Variation of the parameters of uric acid after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of uric acid (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  15. Variation of the parameters of blood glucose after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of blood glucose (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  16. Variation of the parameters of glycated hemoglobin "HbA1c" after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of HbA1c (in %) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  17. Variation of the parameters of ASpartate Transaminase "AST" after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of AST (in U/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  18. Variation of the parameters of ALanine Transaminase "ALT" after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of ALT (in U/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  19. Variation of the parameters of gamma-Glutamyl Transferase "gamma-GT" after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of gamma-GT (in U/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  20. Variation of the parameters of alkaline phosphatase after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of alkaline phosphatase (in U/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  21. Variation of the parameters of lipase after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of lipase (in U/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  22. Variation of the parameters of high sensitivity C-Reactive Protein "hs-CRP" after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of hs-CRP (in mg/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  23. Variation of the parameters of sodium after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of sodium (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  24. Variation of the parameters of magnesium after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of magnesium (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  25. Variation of the parameters of potassium after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of potassium (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  26. Variation of the parameters of calcium after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of calcium (in mg/dl) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

  27. Variation of the parameters of Vitamin D after two and four months of treatment

    Time frame: Four months

    Variation of the parameters of Vitamin D (in nmol/l) after two and four months of treatment with calcium-bicarbonate water in relation to baseline, for comparison with the control oligomineral water

Sponsors and collaborators

Lead sponsor

Società Generale delle Acque Minerali S.p.A.

Industry

Registry information

Official study title

Sponsored, Randomized, Double-blind, Single-center Study on the Effect of the Intake of a Calcium-bicarbonate Water (Lete) on Cholesterol Levels

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
May 11, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.