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

NCT07026266 | Active Not Recruiting

• 1 other identifier: LDLete
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

  Four months

Secondary Outcomes (27)

• Variation of the anthropometric data of weight after two and four months of treatment

  Four months

• Variation of the anthropometric data of Body Mass Index "BMI" after two and four months of treatment

  Four months

• Variation of the anthropometric data of abdominal circumference after two and four months of treatment

  Four months

• Variation of blood pressure values after two and four months of treatment

  Four months

• Variation of heart rate after two and four months of treatment

  Four months

Study Arms (2)

"Lete" group

EXPERIMENTAL

Calcium-bicarbonate mineral water "Lete"

Other: Water

"Sorgesana" group

ACTIVE COMPARATOR

Oligomineral water "Sorgesana"

Other: Water

Interventions

Water OTHER

Calcium-bicarbonate mineral water "Lete"

"Lete" group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Società Generale delle Acque Minerali S.p.A.: lead

Study Sites (1)

Hospital San Raffaele

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Water

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Alberto Margonato

  Hospital San Raffaele - Milano (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 18, 2025
• Study Start: September 17, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)