Lactobacillus Acidophilus and Postmenopausal Women

NCT05332626 | Completed Results

• 1 other identifier: 668/21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Post Menopausal Osteoporosis; Mineralization

Keywords

Probiotic; Lactobacillus acidophilus; Calcium status; Bone resorption; Bone formation; Post Menopausal Osteoporosis

Outcome Measures

Primary Outcomes (2)

• Calcium

  measure the calcium concentration in serum and hair

  2 years

• DXA

  bone densitometry analysis

  2 years

Secondary Outcomes (6)

• 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

Study Arms (2)

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

Dietary Supplement: Probiotic group

Placebo group

PLACEBO COMPARATOR

The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks

Dietary Supplement: Placebo group

Interventions

Probiotic group DIETARY_SUPPLEMENT

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)

Probiotic group

Placebo group DIETARY_SUPPLEMENT

The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)

Placebo group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Poznan University of Life Sciences: lead
• Poznan University of Medical Sciences: collaborator

Study Sites (1)

Poznan University of Life Sciences

Poznan, Greater Poland Voivodeship, 60-624, Poland

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Calcinosis; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoporosis; Calcium Metabolism Disorders

Results Point of Contact

• Title: Iskandar Harahap
• Organization: Poznan University of Life Sciences

iskandar.harahap@up.poznan.pl

+48618486330

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trail

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 18, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Locations

PL (1)