Lactobacillus Acidophilus and Postmenopausal Women

NCT ID: NCT05332626

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-07-01

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.

Conditions

Bone Loss; Post Menopausal Osteoporosis; Mineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Probiotic group

Intervention Type: 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)

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: collaborator

Poznan University of Life Sciences

OTHER

Sponsor Role: lead

Responsible Party

Iskandar Harahap

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Poznan University of Life Sciences

Poznan, Greater Poland Voivodeship, Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

668/21

Identifier Type: -

Identifier Source: org_study_id