Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06050018
Eligibility Criteria:
Inclusion Criteria:
* Menopausal status, defined by ≥ 1 year since last menstrual period and/or serum FSH ≥ 30 IU/l
* Normal liver, thyroid, parathyroid and kidney function eGFR \> 60ml/min
* Usual Milk and milk products consumption
Exclusion Criteria:
* Diabetes,
* Prior osteoporotic fracture
* eGFR \<60ml/min.
* Vitamin D 25-OH deficiency \<10 ng/ml.
* Hypercalcemia Ca \> 11.
* Chronic gastrointestinal disease, or acute condition with nausea, vomiting or diarrhea in the past month.
* Bariatric Surgery.
* Known hypersensitivity to milk components or lactose intolerance.
* Vegan/vegetarian
* Treatment with antibiotics or ingestion of prebiotics or probiotics in the 3 months preceding the study.
* Use of anti-osteoporosis medicines (e.g., bisphosphonates, raloxifene, calcitonin, teriparatide, and denosumab) within 36 months before enrollment.
* Use of Hormone replacement therapy, Vitamin K antagonists (e.g., warfarin), heparin, thiazide diuretics, anticonvulsants, aromatase inhibitors.
* Illicit drug abuse or alcoholism within one year prior to study onset;
* Use of glucocorticoids within 3 months prior to study onset.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
48 Years
Maximum Age:
70 Years
Study:
NCT06050018
Study Brief:
Protocol Section:
NCT06050018