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The Effect of Oral Nutritional Supplementation Combined with Personalized Dietary Guidance on Skeletal Muscle Mass and Function in Hemodialysis Patients

The Effect of Oral Nutritional Supplementation Combined with Personalized Dietary Guidance on Skeletal Muscle Mass and Function in Hemodialysis Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124619
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Chronic kidney disease sarcopenia

Interventions

intervention group:Accept personalized dietary guidance combined with oral nutritional supplements (ONS)
control group:receiving personalized dietary guidance

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old, gender not limited, maintenance hemodialysis treatment = 3 months and stable condition. At least one of the following criteria must be met, defined as the risk of malnutrition or sarcopenia: (1) Serum albumin = 35g/L (2) Body mass index (BMI)5% in the past 3-6 months (3) Skeletal Muscle Index (SMI) meets the criteria for sarcopenia (male<7.0kg/m2 or female<5.7kg/m2) 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled malignant tumor (undergoing radiotherapy and chemotherapy), diabetes with poor blood glucose control (HbA1c>9.0%), uncontrolled thyroid dysfunction, and severe liver disease (Child Pugh C) 2. Obesity (BMI>25 kg/m2); 3. 24-hour proteinuria>3.5g; 4. Dialysis adequacy (std Kt/V<2.1); 5. Acute illness (such as severe infection, new cardiovascular and cerebrovascular events), major surgery (abdominal surgery, orthopedic surgery) or trauma occurring within 3 months; 6. Life expectancy<6 months or long-term bed rest; 7. Suffering from diseases that seriously affect digestion and absorption, such as malabsorption syndrome, inflammatory bowel disease, pancreatic dysfunction, etc; 8. Suffering from serious neurological disorders such as stroke, Parkinson's disease, amyotrophic lateral sclerosis, etc., leading to limb dysfunction; 9. Patients who have difficulty swallowing or are allergic or intolerant to the ingredients of the research product; 10. Currently using other nutritional supplements or other nutritional preparations or drugs that may affect the effectiveness of the experiment; 11. Participants in other nutritional intervention clinical trials within the first 30 days of this study; 12. Individuals with cognitive impairment or mental illness (such as depression) are unable to cooperate with the study.

Design outcomes

Primary

MeasureTime frame
Skeletal muscle mass index;grip strength;

Secondary

MeasureTime frame
Serum albumin;Serum prealbumin;Upper arm muscle circumference;Body Mass Index;6-meter walking speed;SGA rating;KDQOL-SFTM Scale rating;Food Diary;

Countries

China

Contacts

Public ContactJing Qian

Huashan Hospital Fudan University

money_0921@163.com+86 52889325

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026