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Efficacy of Bifidobacterium animalis subsp. lactis Ca360 and Vitamin D-Enriched High-Calcium Milk on Musculoskeletal Health in Middle-aged and Older Adults

Effects of probiotic vitamin D and calcium milk powder on musculoskeletal health in middle-aged and elderly people: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122937
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

Blank control group:Do not carry out any formula food/nutritional supplement interventions, maintain daily diet and lifestyle unchanged
during the study period, medical staff will provide routine medical consultations. Collect routine health check indicators data annually according to the study plan.
Regular milk powder group:Carry out a 12-month ordinary milk powder intervention, using specific products from Mengniu for dietary intervention. Routine collection of physical examination indicator da
Vitamin D and calcium milk powder group (VitD + Ca group):Carry out a 12-month intervention with Vitamin D high-calcium milk powder. Use specific products from Mengniu for dietary intervention. Collec
Probiotic vitamin D and calcium milk powder group (BoneCare Plus /Ca360+VitD + Ca group):Carry out a 12-month intervention with probiotic vitamin D high-calcium milk powder, using a specific Mengniu p

Sponsors

West China School of Public Health, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals aged 50 years or older

Exclusion criteria

Exclusion criteria: 1.History of fractures within the past year; 2.Use within the past 6 months of medications that affect bone metabolism (e.g., bisphosphonates, glucocorticoids, parathyroid hormone (PTH), etc.); 3.Diagnosis of severe renal failure, cirrhosis, inflammatory bowel disease, or active malignant tumors; 4.History of surgical treatment for primary hyperparathyroidism within the past year; 5.Known allergy or intolerance to dairy products, Vitamin D or probiotic ingredients; 6.Use of probiotic supplements for more than 3 months in the past; 7.Cognitive impairment or unable to communicate,Failure to sign the informed consent form; 8.Participation in other similar clinical trials.

Design outcomes

Primary

MeasureTime frame
Bone mineral density (BMD);—

Secondary

MeasureTime frame
Muscle strength;Overall body composition;Plasma metabolomics;Blood biochemistry;Complete blood count (CBC);Gut microbiota;Microbiota-derived metabolites;t-P1NP;ß-ctx;25-hydroxyvitamin D;Serum Calcium;Trace elements such as iron;Lifestyle factors(including smoking, alcohol consumption, diet, physical activity, sleep, etc.);Calf circumference;Upper arm circumference;Handgrip strength;QCT-based body composition analysis;—

Countries

China

Contacts

Public ContactShujuan Yang

West China School of Public Health and West China Fourth Hospital, Sichuan University

yangsj@scu.edu.cn+86 189 8084 2145

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026