Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women

Bone Loss Clinical Trial

— LaBon  

Official title:

Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal Osteoporosis in Women?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05332626
• Other study ID #: 668/21
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Bone Loss
• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

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