NCT05332626CompletedNot Applicable
Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal in Women?
Poznan University of Life Sciences1 site in 1 country90 target enrollmentStarted: February 1, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Calcium
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Probiotic group
Experimental
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
Intervention: Probiotic group (Dietary Supplement)
Placebo group
Placebo Comparator
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Intervention: Placebo group (Dietary Supplement)
Outcomes
Primary Outcomes
Calcium
Time Frame: 2 years
measure the calcium concentration in serum and hair
DXA
Time Frame: 2 years
bone densitometry analysis
Secondary Outcomes
- Body Mass(2 years)
- Calcium Intake(2 years)
- Biomarkers of Bone Turnover: CTX(2 years)
- Biomarkers of Bone Turnover: TRAP5b(2 years)
- Biomarkers of Bone Resorption: BSAP(2 years)
- Biomarkers of Bone Resorption: PINP(2 years)
Investigators
Iskandar Harahap
Principal Investigator
Poznan University of Life Sciences
Study Sites (1)
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