Clinical trial NCT07026266: Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels
Official title: Sponsored, Randomized, Double-blind, Single-center Study on the Effect of the Intake of a Calcium-bicarbonate Water (Lete) on Cholesterol Levels
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Società Generale delle Acque Minerali S.p.A.
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Variation of LDL-C values after four months of treatment
timeFrame: Four months
Secondary outcomes:
measure: Variation of the anthropometric data of weight after two and four months of treatment
timeFrame: Four months
measure: Variation of the anthropometric data of Body Mass Index "BMI" after two and four months of treatment
timeFrame: Four months
measure: Variation of the anthropometric data of abdominal circumference after two and four months of treatment
timeFrame: Four months
measure: Variation of blood pressure values after two and four months of treatment
timeFrame: Four months
measure: Variation of heart rate after two and four months of treatment
timeFrame: Four months
measure: Variation of LDL-C values after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of total cholesterol after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of High Density Lipoprotein "HDL" cholesterol after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of triglycerides after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of Lipoprotein a "Lp(a)" after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of Apolipoprotein B-100 after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of Apolipoprotein A1 after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of creatinine after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of uric acid after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of blood glucose after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of glycated hemoglobin "HbA1c" after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of ASpartate Transaminase "AST" after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of ALanine Transaminase "ALT" after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of gamma-Glutamyl Transferase "gamma-GT" after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of alkaline phosphatase after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of lipase after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of high sensitivity C-Reactive Protein "hs-CRP" after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of sodium after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of magnesium after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of potassium after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of calcium after two and four months of treatment
timeFrame: Four months
measure: Variation of the parameters of Vitamin D after two and four months of treatment
timeFrame: Four months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Hospital San Raffaele
Study officials:
affiliation: Hospital San Raffaele - Milano (Italy)
name: Alberto Margonato
role: PRINCIPAL_INVESTIGATOR
References: