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

Società Generale delle Acque Minerali S.p.A.160 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Hypercholesterolemia

Interventions

WaterOTHER

Calcium-bicarbonate mineral water "Lete"

WaterOTHER

Oligomineral water "Sorgesana"

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Hospital San Raffaele

Milan, Italy, Italy

Outcomes

Primary Outcomes

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

Time frame: Four months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Four months

Variation of heart rate after two and four months of treatment

Data from ClinicalTrials.gov

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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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Four months