SarcopeniaNCT07049731
Improvement of Skeletal and Muscle Health in Patients With Sarcopenia by Protein Powder With Resistance Exercise
A study testing Protein powder intervention and Resistance exercise intervention in people with Sarcopenia, run by Weiwei Ma at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein powder intervention and Resistance exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Capital Medical University
Beijing
Weiwei Ma, +8615810307505, weiweima@ccmu.edu.cn
About this study
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
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
- Being tested
- Protein powder intervention, Resistance exercise intervention, Placebo control
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein powder interventionDietary 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 interventionBehavioural
Low-intensity resistance training was conducted 3 times a week.
Placebo controlDietary supplement
placebo was given and an individualized balanced dietary plan based on the Dietary Guidelines for Chinese Residents was provided.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo control |
| Protein powder intervention group | Experimental | Not described Receives: Dietary Supplement: Protein powder intervention |
| Resistance exercise+placebo control group | Experimental | Not described Receives: Behavioral: Resistance exercise intervention; Dietary Supplement: Placebo control |
| Resistance exercise + protein powder intervention group | Experimental | Not described Receives: Dietary Supplement: Protein powder intervention; Behavioral: Resistance exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extremity Skeletal Muscle Mass Index (ASMI)
ASM was measured using BIA, ASMI=ASM/height (m)^2.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, month 3, month 6
Secondary outcomes (19)
General survey
Using a questionnaire designed by the research team and validated by the previous study, the survey covered the age, gender, ethnicity, marital status, occupation, education level, place of residence, household income, living status (living alone and with family), dietary habits and application of nutritional supplements, lifestyle (smoking, drinking, and physical activity), family history, and chronic diseases (hypertension, diabetes, etc.) of the study participants, Hyperlipidemia, etc.)
Measured: Baseline, month 6
Height
Measure the height of the subjects
Measured: Baseline, month 3, month 6
Weight
Measure the weight of the subjects
Measured: Baseline, month 3, month 6
Body Mass Index(BMI)
Calculate BMI using height and weight , BMI=weight/(height)^2
Measured: Baseline, month 6
Waist circumference, hip circumference, and waist to hip ratio
Measure the waist and hip circumference of the subjects and calculate the waist to hip ratio (waist circumference/hip circumference).
Measured: Baseline, month 3, month 6
Body composition
Using a human body composition analyzer to detect indicators such as total score, visceral fat area, body segment fat and basal metabolic rate, body cell mass, and limb skeletal muscle mass index.
Measured: Baseline, month 6
Assessment of ability to perform activities of daily living
The ADL was assessed using the Activity of Daily Living Scale (ADL), which consists of 10 items, including eating, bathing, grooming, dressing, bowel control, urination control, toileting, bed and chair transfers, walking, and walking up and down stairs.
The total score is 100, with a score of more than 60 indicating mild functional impairment but basic self-care in daily life; a score of 60-41 indicating moderate functional impairment and need for some assistance in daily life; a score of 40-21 indicating severe functional impairment and obvious need for dependence on others in daily life; and a score of less than 20 indicating complete disability and total dependence on others in daily life.
Measured: Baseline, month 3, month 6
Sleep assessment
The PSQI (Pittsburgh Sleep Quality Index) questionnaire was used to assess the quality of the subjects' sleep during the last 1 month. It consists of 19 self-assessment and 5 other-assessment entries, of which the 19th self-assessment and 5 other-assessment entries are not involved in scoring. The cumulative score of each component is the total PSQI score, which ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline, month 3, month 6
Analysis of dietary intake
The 3-day, 24-hour dietary recall method was used to investigate the subjects' dietary intake. The survey process was supplemented with tools such as the "Retrospective Dietary Survey Auxiliary Chart" to help the subjects accurately recall their dietary intake. Based on the Standardized Version of the Chinese Food Composition Table (6th Edition), the energy and various types of protein, fat and carbohydrate intake of the population were calculated, and for the missing data in the Chinese Food Composition Table, the United States Department of Agriculture Food Composition Table was used to supplement the data, so as to build up a comprehensive database of dietary intake. The analysis of dietary intake included the intake of total fat, total protein, total carbohydrates and energy and its percentage in the total energy intake.
Measured: Baseline, month 6
Assessment of overall cognitive functioning
Subjects were assessed for overall cognitive functioning using the Montreal cognitive assessment (MoCA) scale out of 30, which contains cognitive functioning tests in multiple dimensions of visuospatial and executive functioning, naming, memory, attention, language, abstraction, delayed recall, and orientation.The normal threshold is usually ≥ 26 points, 21-25 points indicate mild cognitive impairment, and ≤ 20 points may indicate dementia risk
Measured: Baseline, month 6
Bone density
Bone density, lumbar spine bone density (lumbar 2 - lumbar 4) and left femoral neck bone density are examined using the dualenergy X-ray absorptiometry (DXA) method.
Measured: Baseline, month 6
Knee joint ultrasound
Ultrasound was used to examine the knee joint cavity for fluid or synovial hyperplasia and the tendon ligaments and muscles around the knee joint for damage.
Measured: Baseline, month 6
Knee injury and osteoarthritis outcome score (KOOS score)
The KOOS rating includes five independent evaluation dimensions, each calculated separately and converted into a percentage scale (0-100 points, with higher scores indicating better functionality)
Measured: Baseline, month 3, month 6
Serum sarcopenia related factors
Detect serum calcium (Ca), phosphorus (P), serum hydroxyvitamin D (25(OH)D), serum parathyroid hormone (PTH), P-alkaline phosphatase (ALP), serum osteocalcin (OC), serum type 1 pro-collagen N-terminal pre-peptide, serum type 1 collagen cross-linking N-terminal peptide (NTX), and serum anti-tartrate acid phosphatase 5b (TRACP-5b), estradiol (E2), leptin (LP), and so on.
Measured: Baseline, month 6
Blood lipid concentration
Determine the serum levels of blood lipid concentration in the population. Lipid tests include total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C).
Measured: Baseline, month 6
Blood glucose concentration
Blood glucose tests are fasting blood glucose.
Measured: Baseline, month 6
Insulin concentration
Measurement of insulin secretion level.
Measured: Baseline, month 6
Inflammation-related biochemical indicators
Detecting inflammatory cytokine concentration: including TNF-α, IL-1 α, IL-1 β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-10 and other inflammatory factors.
Measured: month 6
Detection of intestinal flora species, quantity and differentiation level in human population
The collected feces were subjected to 16S rRNA sequencing technology to detect the diversity of gut microbiota.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weiwei Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Capital Medical University, Beijing Friendship Hospital
- Responsible party
- Sponsor-investigator, Weiwei Ma, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049731
- Sponsor's protocol ID
- Z2025SY021
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07049731
- Acronym / sponsor ID
- Z2025SY021
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Weiwei MaUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Capital Medical University, Beijing Friendship Hospital
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria for sarcopenia AWGS 2019
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein powder interventionOn the basis of a balanced diet, 2 sachets of Aiben Leap Protein Nutritional Powder (each sachet containing 6g of milk protein) were supplemented daily. | Dietary supplement | Protein powder intervention group, Resistance exercise + protein powder intervention group |
| Resistance exercise interventionLow-intensity resistance training was conducted 3 times a week. | Behavioural | Resistance exercise + protein powder intervention group, Resistance exercise+placebo control group |
| Placebo controlplacebo was given and an individualized balanced dietary plan based on the Dietary Guidelines for Chinese Residents was provided. | Dietary supplement | Placebo control group, Resistance exercise+placebo control group |
Primary outcome
Extremity Skeletal Muscle Mass Index (ASMI)
Time frame: Baseline, month 3, month 6
ASM was measured using BIA, ASMI=ASM/height (m)^2.
Handgrip strength
Time frame: Baseline, month 3, month 6
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.
6m walking speed
Time frame: Baseline, month 3, month 6
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.
Chair sitting and standing test
Time frame: Baseline, month 3, month 6
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.
Simple Physical Performance Battery (SPPB)
Time frame: Baseline, month 3, month 6
The SPPB consists of 3 test items, each item is scored out of 4 points, and the total score is 12.
19 secondary outcomes
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
Knee injury and osteoarthritis outcome score (KOOS score)
Time frame: Baseline, month 3, month 6
Serum sarcopenia related factors
Time frame: Baseline, month 6
Blood lipid concentration
Time frame: Baseline, month 6
Blood glucose concentration
Time frame: Baseline, month 6
Insulin concentration
Time frame: Baseline, month 6
Inflammation-related biochemical indicators
Time frame: month 6
Detection of intestinal flora species, quantity and differentiation level in human population
Time frame: month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein powder intervention and Resistance exercise intervention in people with Sarcopenia, run by Weiwei Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Ma (+8615810307505, weiweima@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extremity Skeletal Muscle Mass Index (ASMI) (time frame: Baseline, month 3, month 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.