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Nutritional Intervention for the Treatment Effect Evaluation of Osteoporosis with Sarcopenia or Sarcopenia Probable Patients: A Clinical Randomized Controlled Trial

Nutritional Intervention for the Treatment Effect Evaluation of Osteoporosis with Sarcopenia or Sarcopenia Probable Patients: A Clinical Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079213
Enrollment
Unknown
Registered
2023-12-27
Start date
2023-12-30
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Osteoporosis with Sarcopenia or Sarcopenia Probable

Interventions

Intervention group:Comprehensive nutrient supplementation
Control group:Routine health education lectures

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 95 Years

Inclusion criteria

Inclusion criteria: (1) Age: =50 years old, gender unrestricted; (2) Diagnosis of sarcopenia or sarcopenia-like conditions (according to the Chinese Expert Consensus on Diagnosis and Treatment of Sarcopenia in the Elderly (2021)): Skeletal muscle mass index of limbs: Men <7.0 kg/m2, Women <5.4 kg/m2 (measured by dual-energy X-ray absorptiometry (DXA)); Grip strength: Men <28 kg, Women <18 kg; Physical function: 6m walking speed <1.0 m/s or 5 times sit-to-stand =12s or Short Physical Performance Battery (SPPB) =9; (3) Diagnosis of osteoporosis according to the World Health Organization (WHO) criteria: T-score =-2.5; (4) Independent in activities of daily living, no need for special care, and no adverse lifestyle habits such as alcohol abuse; (5) Voluntarily participating in this trial and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Severe stroke, cognitive impairment, or significant mobility limitations; (2) History of severe mental illness, or individuals with understanding, hearing, or visual impairments that prevent normal communication; (3) Severe gastrointestinal diseases (such as severe chronic diarrhea, nausea, vomiting, gastrointestinal obstruction, inflammatory bowel disease) or severe malnutrition; (4) Contraindications to exercise: individuals with severe skeletal muscle disorders, or significant organ dysfunctions in the heart, liver, kidneys, etc., with a history of spinal nerve injury, etc.; (5) Major comorbidities (e.g., diabetes with severe complications, severe kidney disease, malignancy, etc.); (6) Presence of implanted electronic devices or metal in the body; (7) Allergy to the intervention diet; (8) Currently participating in other clinical trial projects; (9) Signs of other major medical or psychological illnesses, or participants deemed unsuitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Appendicular muscle mass;Grip strength;6 meters of pace;Five sit-up times;SPPB;Femoral neck, lumbar spine (L1-L4), and total hip bone mineral density;Femoral neck, lumbar spine (L1-L4), and total hip bone mineral content;

Secondary

MeasureTime frame
Calf circumference;Upper arm circumference;Visceral fat area;Body weight;Body mass index;Waist circumference;Hip circumference;

Countries

China

Contacts

Public ContactPan Youjin

The Second Affiliated Hospital of Wenzhou Medical University

panyj6190@163.com+86 138 5779 5918

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026