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

Società Generale delle Acque Minerali S.p.A.

Status: Active, not recruiting

Conditions: Hypercholesterolemia

Treatments: Other: Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT07026266

LDLete

Details and patient eligibility

About

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

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

"Lete" group

Experimental group

Description:

Calcium-bicarbonate mineral water "Lete"

Treatment:

Other: Water

Other: Water

"Sorgesana" group

Active Comparator group

Description:

Oligomineral water "Sorgesana"

Treatment:

Other: Water

Other: Water