Bone Loss Clinical Trial
— LaBonOfficial title:
Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal Osteoporosis in Women?
Verified date | November 2023 |
Source | Poznan University of Life Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Women aged 45 to 70 years old with more than one year since last menstruation; 2. Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2; 3. All female participants who accepted bone densitometry measurement Exclusion Criteria: 1. The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery; 2. Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome; 3. Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment 4. Clinically significant acute inflammatory process (elevated hsCRP) 5. Abnormal kidney function (GFR <60mL/min/1,73m2); 6. Participation in a body mass management study; 7. The use of drugs known to modify body mass or food intake; 8. Hormone replacement therapy; 9. History of following alternative diets (diets with the altered amount of macronutrients, vegan or vegetarian diets, high-fiber diet, a diet with high quantities of fermented food (>400 g/day), diet fortified with prebiotics- and probiotics-functional food, elimination diets, low-calorie diets) within three months before the study; 10. History of use of any dietary supplements, including calcium, in the three months before the study; 11. History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study; 12. Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention; 13. Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention; 14. Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention; 15. Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics); 16. Diseases requiring nutritional requirement and chronic supplementation; 17. Alcohol (>20g/d), nicotine or drug abuse; 18. Mental disorders, including eating disorders; 19. Cancer, autoimmune diseases; 20. Any other condition that, in the opinion of the investigators, would make participation not in the best interest of the subject, or could prevent, limit, or confound the efficacy of the study any diseases, disorders, and therapies, which may influence on final results of the study or pose a risk for subjects health. |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Life Sciences | Poznan | Wielkopolskie |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Life Sciences | Poznan University of Medical Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | calcium | measure the calcium concentration in serum and hair | 2 years | |
Primary | DXA | bone densitometry analysis | 2 years | |
Secondary | body mass | measure body mass in kilograms | 2 years | |
Secondary | height | measure height in meters | 2 years | |
Secondary | calcium intake | assessing calcium intake with the questionnaire | 2 years | |
Secondary | biomarkers of bone turnover: CTX | measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum | 2 years | |
Secondary | biomarkers of bone turnover: TRAP5b | measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum | 2 years | |
Secondary | biomarkers of bone resorption: BSAP | measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum | 2 years | |
Secondary | biomarkers of bone resorption: PINP | measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum | 2 years | |
Secondary | biomarkers of bone metabolism: PTH | measure the concentration of parathyroid hormone (PTH) in serum | 2 years | |
Secondary | biomarkers of bone metabolism: IGF 1 | measure the concentration of insuline-like growth factor-1 in serum | 2 years | |
Secondary | biomarkers of bone metabolism: high-molecular-weight adiponectin | measure the concentration of high-molecular-weight-adiponectin in serum | 2 years | |
Secondary | gene polymorphism | measure the gene polymorphism Fok1 and Col1A1 in blood | 1 year |
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