Comparing high-calcium and low-calcium water for bone health
Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study
This study is testing whether drinking high-calcium water is better for bone health than low-calcium water in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05772364 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic responses of calcium and parathyroid hormone in healthy adults after consuming low-calcium water followed by high-calcium water. A cohort of 41 participants will be monitored for changes in blood and urine calcium levels. The study aims to understand how different calcium levels in water affect bone health and metabolism. Participants will maintain their usual diet and physical activity throughout the study.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a body mass index between 18 and 30 who can adhere to the study protocol.
Not a fit: Patients with existing cardiac, vascular, renal, or oncological diseases, as well as those on medications affecting bone health, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal calcium intake for improving bone health.
How similar studies have performed: While similar studies on calcium intake and bone health exist, this specific approach comparing high and low-calcium water is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index ≥ 18 and \< 30 * Maintenance of diet and physical activity lifestyle throughout the duration of the study * Acceptance of informed consent Exclusion Criteria: * Consumption of water with calcium \> 150 mg/L * Pregnancy (as established by self-declaration), breastfeeding, menopause * Inability to follow the study protocol * Cardiac, vascular, renal, and oncological disease * Neuropsychiatric disease, developmental disorders * Disease or past surgery affecting the gastrointestinal tract * Drugs that interfere with bone (e.g. corticosteroids) or with fluid balance (e.g. diuretics)
Where this trial is running
Milan
- IRCCS Istituto Ortopedico Galeazzi — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Matteo Briguglio — IRCCS Istituto Ortopedico Galeazzi
- Study coordinator: Elena Cittera
- Email: elena.cittera@grupposandonato.it
- Phone: 00390283502224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.