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

NCT07049731 | Not Yet Recruiting

• 1 other identifier: Z2025SY021
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (5)

• Extremity Skeletal Muscle Mass Index (ASMI)

  ASM was measured using BIA, ASMI=ASM/height (m)\^2.

  Baseline, month 3, month 6

• Handgrip strength

  Maximum force grip was held for 3 seconds, the right and left hands were measured alternately, 3 measurements were taken in each hand, and the maximum value was taken.

  Baseline, month 3, month 6

• 6m walking speed

  Let the tester start from the starting point, walk 6 meters at normal walking speed, stop when reaching the end point, record the time used, and calculate the 6m walking speed according to the time used and the distance of 6 meters.

  Baseline, month 3, month 6

• Chair sitting and standing test

  The subject sat in the center of the chair, crossed his/her arms in front of his/her chest, and after hearing the command "start", he/she completed 5 consecutive times of standing up and sitting down, and recorded the total time in seconds.

  Baseline, month 3, month 6

• Simple Physical Performance Battery (SPPB)

  The SPPB consists of 3 test items, each item is scored out of 4 points, and the total score is 12.

  Baseline, month 3, month 6

Secondary Outcomes (19)

• General survey

  Baseline, month 6

• Height

  Baseline, month 3, month 6

• Weight

  Baseline, month 3, month 6

• Body Mass Index(BMI)

  Baseline, month 6

• Waist circumference, hip circumference, and waist to hip ratio

  Baseline, month 3, month 6

Study Arms (4)

Placebo control group

PLACEBO COMPARATOR

Dietary Supplement: Placebo control

Protein powder intervention group

EXPERIMENTAL

Dietary Supplement: Protein powder intervention

Resistance exercise+placebo control group

EXPERIMENTAL

Behavioral: Resistance exercise intervention; Dietary Supplement: Placebo control

Resistance exercise + protein powder intervention group

EXPERIMENTAL

Dietary Supplement: Protein powder intervention; Behavioral: Resistance exercise intervention

Interventions

Protein powder intervention DIETARY_SUPPLEMENT

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.

Protein powder intervention group; Resistance exercise + protein powder intervention group

Resistance exercise intervention BEHAVIORAL

Low-intensity resistance training was conducted 3 times a week.

Resistance exercise + protein powder intervention group; Resistance exercise+placebo control group

Placebo control DIETARY_SUPPLEMENT

placebo was given and an individualized balanced dietary plan based on the Dietary Guidelines for Chinese Residents was provided.

Placebo control group; Resistance exercise+placebo control group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weiwei Ma: lead
• Beijing Jishuitan Hospital, Capital Medical University: collaborator
• Capital Medical University: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Weiwei Ma

CONTACT

+8615810307505; weiweima@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)