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

NCT06851676 | Recruiting

• 1 other identifier: FOCUS01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Osteopenia, Osteoporosis; Sarcopenia

Keywords

osteoporosis; sarcopenia; functioning; calcium; water

Outcome Measures

Primary Outcomes (1)

• Bioimpedance Analysis (BIA)

  Bioimpedance Analysis (BIA) is a non-invasive method used to assess body composition, including fat mass, muscle mass, and total body water. It works by measuring the resistance of electrical currents as they pass through the body's tissues, with lean tissues (muscle and water) conducting electricity better than fat tissues.

  0 (T0), 180 (T1), and 365 days (T2)

Secondary Outcomes (1)

• Laboratory Tests

  0 (T0), 180 (T1), and 365 days (T2)

Study Arms (2)

intervention

EXPERIMENTAL

Enrolled patients will be divided into three groups: patients with osteoporosis/osteopenia accompanied by sarcopenia, patients with osteoporosis/osteopenia without sarcopenia, and a control group with non-osteometabolic conditions. Each group has been randomized into two subgroups: one receiving Fonte Fausta® and the other receiving natural mineral water.

Dietary Supplement: water supplemented by calcium

control

PLACEBO COMPARATOR

Enrolled patients will be divided into three groups: patients with osteoporosis/osteopenia accompanied by sarcopenia, patients with osteoporosis/osteopenia without sarcopenia, and a control group with non-osteometabolic conditions. Each group has been randomized into two subgroups: one receiving Fonte Fausta® and the other receiving natural mineral water.

Other: Water (Placebo)

Interventions

water supplemented by calcium DIETARY_SUPPLEMENT

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.

intervention

Water (Placebo) OTHER

a natural mineral commercially available

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• a diagnosis of primary osteopenia or osteoporosis , with or without sarcopenia, based on the latest clinical practice guidelines and EWGSOP2 criteria .

You may not qualify if:

• secondary causes of osteoporosis (such as prolonged high-dose glucocorticoid use, liver or kidney disease, cancer, neurodegenerative or inflammatory diseases, chronic obstructive pulmonary disease, and endocrine disorders)
• psychiatric disorders that could impair informed consent
• pregnancy or breastfeeding.

Sponsors & Collaborators

• ANTIMO: lead
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

Vico de Crecchio

Naples, Italy, 80100, Italy

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic; Sarcopenia; Osteoporosis

Interventions

Water

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Antimo Moretti, prof

CONTACT

+390815665526; antimo.moretti@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: July 10, 2024
• Primary Completion: July 10, 2025
• Study Completion: September 10, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)