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A multi center randomized controlled clinical study of isolated whey protein plus HMB and VD3 combined with exercise rehabilitation in elderly patients with sarcopenia

A multi center randomized controlled clinical study of isolated whey protein plus HMB and VD3 combined with exercise rehabilitation in elderly patients with sarcopenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077187
Enrollment
Unknown
Registered
2023-11-01
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

sarcopenia

Interventions

Intervention group:Dietary exercise guidance+nutritional supplementation+exercise intervention
Control group:Dietary exercise guidance

Sponsors

Huadong hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosed with sarcopenia (according to the Asian Sarcopenia Working Group AWGS 2019 diagnostic criteria) ? Skeletal muscle mass index of limbs: male <7.0kg/m2, female <5.7kg/m2 (bioelectrical impedance BIA assay was used in this study); ? Grip strength: male <28kg, female <18kg and/or 5 sitting times ?12s/6m Walking speed <1.0m/s (2) Age: =65 years old, gender is not limited (3) Self-care, no need for special care, no bad habits such as alcoholism (4) have lived locally for nearly 3 months and are not expected to leave their residence within 6 months (5) Voluntarily participate in this experiment and sign the informed consent

Exclusion criteria

Exclusion criteria: (1) Patients with severe stroke, cognitive dysfunction and mobility impairment (2) Previous history of mental illness, or understanding, hearing, visual impairment, unable to communicate normally (3) People with severe gastrointestinal diseases (severe chronic diarrhea, nausea, vomiting, gastrointestinal obstruction, inflammatory bowel disease, etc.) or severe malnutrition (4) There are sports contraindications: such as serious musculoskeletal disorders or heart, liver, kidney and other important organ insufficiency; History of spinal nerve injury (5) Implantation of electronic devices or metals in the body (6) People who may be allergic to the intervention diet (7) Those who are taking various protein supplements (equivalent to an additional daily supplement of protein ?10g) or participating in other clinical trials (8) There are other signs of significant medical or mental illness that the respondent considers unsuitable for participating in the study(YNMT)·

Design outcomes

Primary

MeasureTime frame
Skeletal muscle index(SMI);Grip;SPPB;MNA-SF;FRAIL;25(OH)D3;Calf circumference;

Secondary

MeasureTime frame
24h Dietary survey;EQ-5D;BMI;Liver function;Renal function;

Countries

CHINA

Contacts

Public ContactJianqin Sun

Huadong hospital affiliated to Fudan University

jianqins@163.com+86 136 8182 5732

Outcome results

None listed

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