Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women (LaBon)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Loss; Post Menopausal Osteoporosis; Mineralization
• Intervention / Treatment: Dietary supplement: Probiotic group; Dietary supplement: Placebo group

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 60-624
      • Poznan University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10^9 CFU for 12 weeks	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 Comparator: Placebo group; The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks	Dietary supplement: Placebo group; The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calcium	measure the calcium concentration in serum and hair	2 years
DXA	bone densitometry analysis	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass	measure body mass in kilograms	2 years
height	measure height in meters	2 years
calcium intake	assessing calcium intake with the questionnaire	2 years
biomarkers of bone turnover: CTX	measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum	2 years
biomarkers of bone turnover: TRAP5b	measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum	2 years
biomarkers of bone resorption: BSAP	measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum	2 years
biomarkers of bone resorption: PINP	measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum	2 years
biomarkers of bone metabolism: PTH	measure the concentration of parathyroid hormone (PTH) in serum	2 years
biomarkers of bone metabolism: IGF 1	measure the concentration of insuline-like growth factor-1 in serum	2 years
biomarkers of bone metabolism: high-molecular-weight adiponectin	measure the concentration of high-molecular-weight-adiponectin in serum	2 years
gene polymorphism	measure the gene polymorphism Fok1 and Col1A1 in blood	1 year

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Collaborators: Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Probiotic; Bone formation; Bone resorption; Lactobacillus acidophilus; Calcium status; Post Menopausal Osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: 668/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No