Status:
UNKNOWN
Milk on Gut Microbiome and Bone Remodeling CTX in Postmenopausal Women
Lead Sponsor:
Tel Aviv University
Collaborating Sponsors:
Wolfson Medical Center
Conditions:
Menopause
Eligibility:
FEMALE
48-70 years
Phase:
NA
Brief Summary
Milk consumption drives beneficial effect on Bone Mass Density and on Gut Microbiome. Altered Gut Microbiome is associated with postmenopausal status, reduced Bone Mass Density, abnormal serum levels ...
Detailed Description
Milk consumption is associated with favorable effects on Bone Mass Density, prevention of osteoporosis and beneficial changes in Gut Microbiome. Alteration of Fecal or Gut Microbiome (dysbiosis) is re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06050018
Start Date
October 1 2023
End Date
December 1 2024
Last Update
September 22 2023
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