NCT07026266Completed
Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels
Sponsored, Randomized, Double-blind, Single-center Study on the Effect of the Intake of a Calcium-bicarbonate Water (Lete) on Cholesterol Levels
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 30 May 2025
- Start date
- 17 Sept 2025
- Primary completion date
- 3 Apr 2026
- Lead sponsor
- Società Generale delle Acque Minerali S.p.A.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07026266
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 17 Sept 2025 to the primary completion date, 3 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- treatment with drugs that could influence lipid metabolism (estrogen replacement hormone therapy, corticosteroid therapy, insulin therapy)
Other illness
- diabetes mellitus
- arterial hypertension
- gastrointestinal (e.g. gastro-duodenal ulcer, ulcerative colitis, diverticulosis of the colon, etc.), liver or renal diseases
Other
- BMI \< 20 and \> 30 kg/m2
- familial hypercholesterolemia
- Consumers of fortified foods that could influence lipid metabolism (containing n-3 fatty acids or phytosterols)
Who the study is looking for
- 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.)
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.