Clinical trial NCT05332626: Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women
Official title: Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal Osteoporosis in Women?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Loss
Post Menopausal Osteoporosis
Mineralization
Keywords: Probiotic
Lactobacillus acidophilus
Calcium status
Bone resorption
Bone formation
Post Menopausal Osteoporosis
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
Collaborators: name: Poznan University of Medical Sciences
First posted: 2022-04-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trail
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study has three steps; namely, 1st step is to prepare the diet supplementation of probiotics and placebo. 2nd step is to perform the randomized, double-blind placebo-controlled clinical trial. 3rd step is to analyze the effects of L. acidophilus UALa-01™ in postmenopausal women.

Eligibility criteria: 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.

Primary outcomes:
measure: calcium
timeFrame: 2 years
measure: DXA
timeFrame: 2 years
Secondary outcomes:
measure: body mass
timeFrame: 2 years
measure: height
timeFrame: 2 years
measure: calcium intake
timeFrame: 2 years
measure: biomarkers of bone turnover: CTX
timeFrame: 2 years
measure: biomarkers of bone turnover: TRAP5b
timeFrame: 2 years
measure: biomarkers of bone resorption: BSAP
timeFrame: 2 years
measure: biomarkers of bone resorption: PINP
timeFrame: 2 years
measure: biomarkers of bone metabolism: PTH
timeFrame: 2 years
measure: biomarkers of bone metabolism: IGF 1
timeFrame: 2 years
measure: biomarkers of bone metabolism: high-molecular-weight adiponectin
timeFrame: 2 years
measure: gene polymorphism
timeFrame: 1 year
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
state: Wielkopolskie
Study officials:
References: