Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women

Study Overview
=================
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.

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

Conditions
-----------------
Bone Loss, Post Menopausal Osteoporosis, Mineralization

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic group
* Dietary Supplement: Placebo group


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trail
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>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<br>* 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)<br>|
| Placebo Comparator: Placebo group<br>The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks | Dietary Supplement: Placebo group<br>* The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic, Lactobacillus acidophilus, Calcium status, Bone resorption, Bone formation, Post Menopausal Osteoporosis