Bone Loss, Mineralization, Post Menopausal Osteoporosis
Conditions
Keywords
Probiotic, Lactobacillus acidophilus, Calcium status, Bone resorption, Bone formation, Post Menopausal Osteoporosis
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.
Interventions
DIETARY_SUPPLEMENTProbiotic 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)
DIETARY_SUPPLEMENTPlacebo group
The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
Sponsors
Poznan University of Medical Sciences
Poznan University of Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized Controlled Trail
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcium | 2 years | measure the calcium concentration in serum and hair |
| DXA | 2 years | bone densitometry analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of Bone Turnover: CTX | 2 years | measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum |
| Biomarkers of Bone Turnover: TRAP5b | 2 years | measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum |
| Body Mass | 2 years | measure body mass in kilograms |
| Biomarkers of Bone Resorption: PINP | 2 years | measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum |
| Biomarkers of Bone Resorption: BSAP | 2 years | measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum |
| Calcium Intake | 2 years | assessing calcium intake with the questionnaire |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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) | 32 |
| Placebo Group The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people) | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Probiotic Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 64 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 5.8 | 58.1 years STANDARD_DEVIATION 6.3 | 59.6 years STANDARD_DEVIATION 6.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Poland | 32 participants | 64 participants | 32 participants |
| Sex: Female, Male Female | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 25 |
| other Total, other adverse events | 0 / 30 | 0 / 25 |
| serious Total, serious adverse events | 0 / 30 | 0 / 25 |
Outcome results
Primary
Calcium
measure the calcium concentration in serum and hair
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Calcium | 1.88 mmol/L | Standard Deviation 0.44 |
| Placebo Group | Calcium | 2.04 mmol/L | Standard Deviation 0.09 |
Primary
DXA
bone densitometry analysis
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | DXA | 1.12 g/cm2 | Standard Deviation 0.12 |
| Placebo Group | DXA | 1.15 g/cm2 | Standard Deviation 0.11 |
Secondary
Biomarkers of Bone Resorption: BSAP
measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Biomarkers of Bone Resorption: BSAP | 10.90 ng/ml | Standard Deviation 1.56 |
| Placebo Group | Biomarkers of Bone Resorption: BSAP | 11.38 ng/ml | Standard Deviation 1.96 |
Secondary
Biomarkers of Bone Resorption: PINP
measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Biomarkers of Bone Resorption: PINP | 2.64 ng/ml | Standard Deviation 0.52 |
| Placebo Group | Biomarkers of Bone Resorption: PINP | 2.66 ng/ml | Standard Deviation 0.52 |
Secondary
Biomarkers of Bone Turnover: CTX
measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Biomarkers of Bone Turnover: CTX | 5.67 pg/ml | Standard Deviation 0.52 |
| Placebo Group | Biomarkers of Bone Turnover: CTX | 5.11 pg/ml | Standard Deviation 0.52 |
Secondary
Biomarkers of Bone Turnover: TRAP5b
measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Biomarkers of Bone Turnover: TRAP5b | 26.09 ng/ml | Standard Deviation 9.31 |
| Placebo Group | Biomarkers of Bone Turnover: TRAP5b | 21.13 ng/ml | Standard Deviation 6.33 |
Secondary
Body Mass
measure body mass in kilograms
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Body Mass | 72.22 kg | Standard Deviation 15.21 |
| Placebo Group | Body Mass | 73.88 kg | Standard Deviation 13.45 |
Secondary
Calcium Intake
assessing calcium intake with the questionnaire
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Group | Calcium Intake | 1,115.81 gram | Standard Deviation 529.76 |
| Placebo Group | Calcium Intake | 894.72 gram | Standard Deviation 381.84 |