Improvement of Skeletal and Muscle Health in Patients With Sarcopenia by Protein Powder With Resistance Exercise

Official title

Improvement of Skeletal and Muscle Health in Patients With Sarcopenia by AIBEN YUEDONG Protein Nutrition Powder in Combination With a Resistance Exercise Intervention

Overview

Sarcopenia is an age-related progressive skeletal muscle disease, the prevalence of which is increasing year by year with the aging of China's population, seriously affecting the health and quality of life of the elderly. Relevant studies have shown that protein intake in combination with resistance exercise can significantly improve muscle mass and function, and the effect is superior to that of a single intervention. In addition, ingredients such as vitamin D, N-acetylglucosamine, sodium hyaluronate, and taurine can further promote muscle health by regulating metabolism and inflammation levels. However, there are relatively few intervention studies combining the above nutrients with resistance exercise in patients with sarcopenia. Therefore, this study intends to use protein powder containing milk protein, vitamin D, N-acetylglucosamine, sodium hyaluronate, taurine and other ingredients, combined with low-intensity resistance exercise, to intervene in the middle-aged and elderly patients with sarcopenia, and to explore and observe the effects on muscle mass, bone density, intestinal health and other indexes of patients with sarcopenia, with the aim of providing a more accurate nutritional and exercise intervention program for the prevention and treatment of sarcopenia.

Interventions

• Dietary supplement Protein powder intervention
  On the basis of a balanced diet, 2 sachets of Aiben Leap Protein Nutritional Powder (each sachet containing 6g of milk protein) were supplemented daily.
• Behavioral Resistance exercise intervention
  Low-intensity resistance training was conducted 3 times a week.
• Dietary supplement Placebo control
  placebo was given and an individualized balanced dietary plan based on the Dietary Guidelines for Chinese Residents was provided.

Primary outcome measures

• Extremity Skeletal Muscle Mass Index (ASMI) [Time frame: Baseline, month 3, month 6]
• Handgrip strength [Time frame: Baseline, month 3, month 6]
• 6m walking speed [Time frame: Baseline, month 3, month 6]
• Chair sitting and standing test [Time frame: Baseline, month 3, month 6]
• Simple Physical Performance Battery (SPPB) [Time frame: Baseline, month 3, month 6]

Secondary outcome measures (12)

• General survey [Time frame: Baseline, month 6]
• Height [Time frame: Baseline, month 3, month 6]
• Weight [Time frame: Baseline, month 3, month 6]
• Body Mass Index(BMI) [Time frame: Baseline, month 6]
• Waist circumference, hip circumference, and waist to hip ratio [Time frame: Baseline, month 3, month 6]
• Body composition [Time frame: Baseline, month 6]
• Assessment of ability to perform activities of daily living [Time frame: Baseline, month 3, month 6]
• Sleep assessment [Time frame: Baseline, month 3, month 6]
• Analysis of dietary intake [Time frame: Baseline, month 6]
• Assessment of overall cognitive functioning [Time frame: Baseline, month 6]
• Bone density [Time frame: Baseline, month 6]
• Knee joint ultrasound [Time frame: Baseline, month 6]

Eligibility criteria

Inclusion criteria

• Meet the diagnostic criteria for sarcopenia AWGS 2019

• Grip strength less than 28.0 kg for males and less than 18.0 kg for females
• 6-meter stride speed less than 1.0 m/s or 5-repetition sit-up test time ≥ 12 seconds or SPPB ≤ 9 points.
• Bioelectrical Impedance Analysis (BIA) less than 7.0 kg/m² for males and 5.7 kg/m² for females or Dual-energy X-ray absorptiometry (DXA) less than 7.0 kg/m² for males and 5.4 kg/m² for females;
• Age between 35-75 years old with high compliance;
• Complete clinical data;
• Voluntary participation in the program with informed consent and signing of the informed consent form.

Exclusion criteria

• A clear history of allergy to protein powder in the past 6 months, or the presence of diarrhea symptoms and the frequency of ≥ 7 days / month, the duration of more than 2 weeks;
• Major physical diseases (diabetes with serious complications, malignant tumors, serious cardiovascular disease, neurological diseases or other diseases that may affect the effectiveness of exercise and nutritional interventions, etc.);
• The past three months, new fractures and recently underwent joint replacement surgery patients;
• Suffering from congenital bone or muscle diseases;
• The simultaneous existence of other comorbidities affecting muscle metabolism, such as malignant tumors, liver disease, severe organ insufficiency such as nephrotic syndrome, renal failure and other diseases that may affect protein metabolism;
• Participating in other clinical trials patients;
• With sensory disabilities or other reasons significantly affecting the collection of data, such as severe deafness, blindness, mental disorders, etc.;
• The researchers The researchers believe that other reasons are not suitable for clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Capital Medical University — Beijing

Identifiers

NCT: NCT07049731 · Z2025SY021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗