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

NCT ID: NCT07049731

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo control group

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DIETARY_SUPPLEMENT

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

Protein powder intervention group

Group Type EXPERIMENTAL

Protein powder intervention

Intervention Type 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.

Resistance exercise+placebo control group

Group Type EXPERIMENTAL

Resistance exercise intervention

Intervention Type BEHAVIORAL

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

Placebo control

Intervention Type DIETARY_SUPPLEMENT

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

Resistance exercise + protein powder intervention group

Group Type EXPERIMENTAL

Protein powder intervention

Intervention Type 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.

Resistance exercise intervention

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Resistance exercise intervention

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

Intervention Type BEHAVIORAL

Placebo control

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Meet the diagnostic criteria for sarcopenia AWGS 2019

1. Grip strength less than 28.0 kg for males and less than 18.0 kg for females
2. 6-meter stride speed less than 1.0 m/s or 5-repetition sit-up test time ≥ 12 seconds or SPPB ≤ 9 points.
3. 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital, Capital Medical University

UNKNOWN

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Weiwei Ma

OTHER

Sponsor Role lead

Responsible Party

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Weiwei Ma

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Capital Medical University

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Weiwei Ma

Role: CONTACT

+8615810307505

Facility Contacts

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Weiwei Ma

Role: primary

+8615810307505

Other Identifiers

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Z2025SY021

Identifier Type: -

Identifier Source: org_study_id

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