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Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients

NCT06851676 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-28

No results posted yet for this study

Summary

This clinical study investigates the effects of Fonte Fausta® water on bone and muscle metabolism, as well as quality of life, in patients with osteoporosis or osteopenia, with or without sarcopenia. Conducted as a multicenter, triple-arm trial, it evaluates functional and biochemical markers over 12 months. Patients are randomized into groups receiving either Fonte Fausta® or standard mineral water, with assessments including laboratory tests, bioimpedance analysis, physical and nutritional evaluations, bone density measurements, and quality of life surveys.

Conditions

Interventions

DIETARY_SUPPLEMENT

water supplemented by calcium

Fonte Fausta® water is a natural mineral water, rich in essential minerals, such as calcium, magnesium, and bicarbonate, which are important for maintaining bone density, muscle function, and overall metabolic health.

OTHER

Water (Placebo)

a natural mineral commercially available

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • ANTIMO

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-07-10
Completion
2025-09-10

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06851676 on ClinicalTrials.gov