HypercholesterolemiaNCT07026266
Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels
A study testing Water in people with Hypercholesterolemia, run by Società Generale delle Acque Minerali S.p.A. at 1 site in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2025to 3 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sponsored, Randomized, Double-blind, Single-center Study on the Effect of the Intake of a Calcium-bicarbonate Water (Lete) 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
Read the detailed description
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
- Conditions
- Hypercholesterolemia
- Being tested
- Water
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| "Lete" group | Experimental | Calcium-bicarbonate mineral water "Lete" Receives: Other: Water |
| "Sorgesana" group | Active comparator | Oligomineral water "Sorgesana" Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of LDL-C values after four months of treatment
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
Measured: Four months
Secondary outcomes (27)
Variation of the anthropometric data of weight after two and four months of treatment
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
Measured: Four months
Variation of the anthropometric data of Body Mass Index "BMI" after two and four months of treatment
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
Measured: Four months
Variation of the anthropometric data of abdominal circumference after two and four months of treatment
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
Measured: Four months
Variation of blood pressure values after two and four months of treatment
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
Measured: Four months
Variation of heart rate after two and four months of treatment
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
Measured: Four months
Variation of LDL-C values after two and four months of treatment
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
Measured: Four months
Variation of the parameters of total cholesterol after two and four months of treatment
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
Measured: Four months
Variation of the parameters of High Density Lipoprotein "HDL" cholesterol after two and four months of treatment
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
Measured: Four months
Variation of the parameters of triglycerides after two and four months of treatment
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
Measured: Four months
Variation of the parameters of Lipoprotein a "Lp(a)" after two and four months of treatment
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
Measured: Four months
Variation of the parameters of Apolipoprotein B-100 after two and four months of treatment
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
Measured: Four months
Variation of the parameters of Apolipoprotein A1 after two and four months of treatment
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
Measured: Four months
Variation of the parameters of creatinine after two and four months of treatment
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
Measured: Four months
Variation of the parameters of uric acid after two and four months of treatment
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
Measured: Four months
Variation of the parameters of blood glucose after two and four months of treatment
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
Measured: Four months
Variation of the parameters of glycated hemoglobin "HbA1c" after two and four months of treatment
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
Measured: Four months
Variation of the parameters of ASpartate Transaminase "AST" after two and four months of treatment
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
Measured: Four months
Variation of the parameters of ALanine Transaminase "ALT" after two and four months of treatment
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
Measured: Four months
Variation of the parameters of gamma-Glutamyl Transferase "gamma-GT" after two and four months of treatment
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
Measured: Four months
Variation of the parameters of alkaline phosphatase after two and four months of treatment
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
Measured: Four months
Variation of the parameters of lipase after two and four months of treatment
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
Measured: Four months
Variation of the parameters of high sensitivity C-Reactive Protein "hs-CRP" after two and four months of treatment
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
Measured: Four months
Variation of the parameters of sodium after two and four months of treatment
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
Measured: Four months
Variation of the parameters of magnesium after two and four months of treatment
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
Measured: Four months
Variation of the parameters of potassium after two and four months of treatment
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
Measured: Four months
Variation of the parameters of calcium after two and four months of treatment
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
Measured: Four months
Variation of the parameters of Vitamin D after two and four months of treatment
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
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start17 Sep 2025
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Società Generale delle Acque Minerali S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Margonato, Principal investigator, Hospital San Raffaele - Milano (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026266
- Sponsor's protocol ID
- LDLete
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sponsored, Randomized, Double-blind, Single-center Study on the Effect of the Intake of a Calcium-bicarbonate Water (Lete) on Cholesterol Levels
- ClinicalTrials.gov ID
- NCT07026266
- Acronym / sponsor ID
- LDLete
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Società Generale delle Acque Minerali S.p.A.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Lete" group | Experimental | Other: WaterCalcium-bicarbonate mineral water "Lete" |
| "Sorgesana" group | Active comparator | Other: WaterOligomineral water "Sorgesana" |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterCalcium-bicarbonate mineral water "Lete" | Other | "Lete" group |
| WaterOligomineral water "Sorgesana" | Other | "Sorgesana" group |
Primary outcome
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
27 secondary outcomes
Variation of the anthropometric data of weight after two and four months of treatment
Time frame: Four months
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 abdominal circumference after two and four months of treatment
Time frame: Four months
Variation of blood pressure values after two and four months of treatment
Time frame: Four months
Variation of heart rate after two and four months of treatment
Time frame: Four months
Variation of LDL-C values after two and four months of treatment
Time frame: Four months
Variation of the parameters of total cholesterol after two and four months of treatment
Time frame: Four months
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 triglycerides after two and four months of treatment
Time frame: Four months
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 Apolipoprotein B-100 after two and four months of treatment
Time frame: Four months
Variation of the parameters of Apolipoprotein A1 after two and four months of treatment
Time frame: Four months
Variation of the parameters of creatinine after two and four months of treatment
Time frame: Four months
Variation of the parameters of uric acid after two and four months of treatment
Time frame: Four months
Variation of the parameters of blood glucose after two and four months of treatment
Time frame: Four months
Variation of the parameters of glycated hemoglobin "HbA1c" after two and four months of treatment
Time frame: Four months
Variation of the parameters of ASpartate Transaminase "AST" after two and four months of treatment
Time frame: Four months
Variation of the parameters of ALanine Transaminase "ALT" after two and four months of treatment
Time frame: Four months
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 alkaline phosphatase after two and four months of treatment
Time frame: Four months
Variation of the parameters of lipase after two and four months of treatment
Time frame: Four months
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 sodium after two and four months of treatment
Time frame: Four months
Variation of the parameters of magnesium after two and four months of treatment
Time frame: Four months
Variation of the parameters of potassium after two and four months of treatment
Time frame: Four months
Variation of the parameters of calcium after two and four months of treatment
Time frame: Four months
Variation of the parameters of Vitamin D after two and four months of treatment
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Margonato principal investigator
Hospital San Raffaele - Milano (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water in people with Hypercholesterolemia, run by Società Generale delle Acque Minerali S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of LDL-C values after four months of treatment (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.