Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women (LaBon)
Primary Purpose
Bone Loss, Post Menopausal Osteoporosis, Mineralization
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotic group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss focused on measuring Probiotic, Lactobacillus acidophilus, Calcium status, Bone resorption, Bone formation, Post Menopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Women aged 45 to 70 years old with more than one year since last menstruation;
- Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- All female participants who accepted bone densitometry measurement
Exclusion Criteria:
- The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
- Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
- Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
- Clinically significant acute inflammatory process (elevated hsCRP)
- Abnormal kidney function (GFR <60mL/min/1,73m2);
- Participation in a body mass management study;
- The use of drugs known to modify body mass or food intake;
- Hormone replacement therapy;
- 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;
- History of use of any dietary supplements, including calcium, in the three months before the study;
- History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
- Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
- Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- Diseases requiring nutritional requirement and chronic supplementation;
- Alcohol (>20g/d), nicotine or drug abuse;
- Mental disorders, including eating disorders;
- Cancer, autoimmune diseases;
- 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.
Sites / Locations
- Poznan University of Life Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic group
Placebo group
Arm Description
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
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Outcomes
Primary Outcome Measures
calcium
measure the calcium concentration in serum and hair
DXA
bone densitometry analysis
Secondary Outcome Measures
body mass
measure body mass in kilograms
height
measure height in meters
calcium intake
assessing calcium intake with the questionnaire
biomarkers of bone turnover: CTX
measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
biomarkers of bone turnover: TRAP5b
measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
biomarkers of bone resorption: BSAP
measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
biomarkers of bone resorption: PINP
measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
biomarkers of bone metabolism: PTH
measure the concentration of parathyroid hormone (PTH) in serum
biomarkers of bone metabolism: IGF 1
measure the concentration of insuline-like growth factor-1 in serum
biomarkers of bone metabolism: high-molecular-weight adiponectin
measure the concentration of high-molecular-weight-adiponectin in serum
gene polymorphism
measure the gene polymorphism Fok1 and Col1A1 in blood
Full Information
NCT ID
NCT05332626
First Posted
March 23, 2022
Last Updated
April 26, 2022
Sponsor
Poznan University of Life Sciences
Collaborators
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05332626
Brief Title
Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women
Acronym
LaBon
Official Title
Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal Osteoporosis in Women?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Life Sciences
Collaborators
Poznan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Post Menopausal Osteoporosis, Mineralization
Keywords
Probiotic, Lactobacillus acidophilus, Calcium status, Bone resorption, Bone formation, Post Menopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trail
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic group
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
Primary Outcome Measure Information:
Title
calcium
Description
measure the calcium concentration in serum and hair
Time Frame
2 years
Title
DXA
Description
bone densitometry analysis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
body mass
Description
measure body mass in kilograms
Time Frame
2 years
Title
height
Description
measure height in meters
Time Frame
2 years
Title
calcium intake
Description
assessing calcium intake with the questionnaire
Time Frame
2 years
Title
biomarkers of bone turnover: CTX
Description
measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
Time Frame
2 years
Title
biomarkers of bone turnover: TRAP5b
Description
measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
Time Frame
2 years
Title
biomarkers of bone resorption: BSAP
Description
measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
Time Frame
2 years
Title
biomarkers of bone resorption: PINP
Description
measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
Time Frame
2 years
Title
biomarkers of bone metabolism: PTH
Description
measure the concentration of parathyroid hormone (PTH) in serum
Time Frame
2 years
Title
biomarkers of bone metabolism: IGF 1
Description
measure the concentration of insuline-like growth factor-1 in serum
Time Frame
2 years
Title
biomarkers of bone metabolism: high-molecular-weight adiponectin
Description
measure the concentration of high-molecular-weight-adiponectin in serum
Time Frame
2 years
Title
gene polymorphism
Description
measure the gene polymorphism Fok1 and Col1A1 in blood
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 45 to 70 years old with more than one year since last menstruation;
Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
All female participants who accepted bone densitometry measurement
Exclusion Criteria:
The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
Clinically significant acute inflammatory process (elevated hsCRP)
Abnormal kidney function (GFR <60mL/min/1,73m2);
Participation in a body mass management study;
The use of drugs known to modify body mass or food intake;
Hormone replacement therapy;
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;
History of use of any dietary supplements, including calcium, in the three months before the study;
History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
Diseases requiring nutritional requirement and chronic supplementation;
Alcohol (>20g/d), nicotine or drug abuse;
Mental disorders, including eating disorders;
Cancer, autoimmune diseases;
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.
Facility Information:
Facility Name
Poznan University of Life Sciences
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-624
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women
We'll reach out to this number within 24 hrs