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

NCT ID: NCT07026266

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2025-12-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

"Lete" group

Calcium-bicarbonate mineral water "Lete"

Group Type: EXPERIMENTAL

Water

Intervention Type: OTHER

Calcium-bicarbonate mineral water "Lete"

"Sorgesana" group

Oligomineral water "Sorgesana"

Group Type: ACTIVE_COMPARATOR

Water

Intervention Type: OTHER

Oligomineral water "Sorgesana"

Interventions

Water

Calcium-bicarbonate mineral water "Lete"

Intervention Type: OTHER

Water

Oligomineral water "Sorgesana"

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Società Generale delle Acque Minerali S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Margonato

Role: PRINCIPAL_INVESTIGATOR

Hospital San Raffaele - Milano (Italy)

Locations

Hospital San Raffaele

Milan, Italy, Italy

Countries

Italy

Other Identifiers

LDLete

Identifier Type: -

Identifier Source: org_study_id