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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05332626
Other study ID # 668/21
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 2024

Study information

Verified date November 2023
Source Poznan University of Life Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Dietary Supplement:
Probiotic group
The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
Placebo group
The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)

Locations

Country Name City State
Poland Poznan University of Life Sciences Poznan Wielkopolskie

Sponsors (2)

Lead Sponsor Collaborator
Poznan University of Life Sciences Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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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