Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-01 @ 4:05 PM
Study NCT ID:
NCT07026266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels
Sponsor:
Società Generale delle Acque Minerali S.p.A.
Organization:
Study Overview
Official Title:
Sponsored, Randomized, Double-blind, Single-center Study on the Effect of the Intake of a Calcium-bicarbonate Water (Lete) on Cholesterol Levels
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: