SarcopeniaNCT06347835
Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
A study testing symbiotic and whey protein in people with Sarcopenia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- symbiotic and whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and older
- Can cooperate with the measurement and questionnaire survey
- Meets Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria for sarcopenia
- Obtain informed consent to participate in this study
Who cannot join
- Severe complications
- Suffers from neuromuscular related diseases
- Immobility
- Have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks
- Implants of electronic devices or metal objects in the body
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Kang Yu, MD, +86 010-69155550, yuk1997@sina.com
About this study
The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia.
Read the detailed description
This study will last 12 weeks. For the duration of the study, an anticipated total of 120 participants will be randomly assigned to three groups. During the study visits, questionnaires, blood and stool collection, and functional testing will occur. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
- Conditions
- Sarcopenia
- Being tested
- symbiotic, whey protein, symbiotic placebo, whey protein placebo
- Keywords
- Sarcopenia, Gut-muscle Axis, Biomarker, Gut microbiota, Intervention
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symbioticDietary supplement
The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification.
whey proteinDietary supplement
The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification.
symbiotic placeboDietary supplement
The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
whey protein placeboDietary supplement
The intervention is made up of maltodextrin (20g/d) and dietary pattern modification.
| Study group | Role | What they receive |
|---|---|---|
| symbiotic and whey protein intervention | Experimental | This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks Receives: Dietary Supplement: symbiotic; Dietary Supplement: whey protein |
| whey protein intervention | Experimental | This group received dietary guidance and whey protein intervention for 12 weeks Receives: Dietary Supplement: whey protein; Dietary Supplement: symbiotic placebo |
| control | Placebo comparator | This group received dietary guidance and maltodextrin for 12 weeks Receives: Dietary Supplement: symbiotic placebo; Dietary Supplement: whey protein placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks
Defined as muscle mass (Unit: kg/m2)
Measured: 12 weeks
Change from Baseline of grip strength at 12 weeks
Defined as muscle strength (Unit: kg)
Measured: 12 weeks
Secondary outcomes (5)
Change from Baseline of Short Physical Performance Battery score at 12 weeks
Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.
Measured: 12 weeks
Change from Baseline of gait speed at 12 weeks
Defined as gait speed (Unit: m/s)
Measured: 12 weeks
Change from Baseline of gut microbiota composition at 12 weeks
The stool samples of participants before and after intervention will be collected and analyzed by 16S ribosomal RNA (rRNA).
Measured: 12 weeks
Change from Baseline of inflammation status at 12 weeks
Inflammation status will be represented by Interleukin-6 (IL-6), IL-8, IL-10 and Tumour necrosis factor alpha (TNF-α).
Measured: 12 weeks
Change from Baseline of microbiota-derived metabolites at 12 weeks
Microbiota-derived metabolites includes short-chain fatty acids, amino acid metabolites and secondary bile acids.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJan 2026 (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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kang, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347835
- Sponsor's protocol ID
- Gut-Intervention-SAR-2024
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis
- ClinicalTrials.gov ID
- NCT06347835
- Acronym / sponsor ID
- Gut-Intervention-SAR-2024
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Gut-muscle Axis, Biomarker, Gut microbiota, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Apr 2024 (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.
The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia.
Detailed description
This study will last 12 weeks. For the duration of the study, an anticipated total of 120 participants will be randomly assigned to three groups. During the study visits, questionnaires, blood and stool collection, and functional testing will occur. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| symbiotic and whey protein intervention | Experimental | Dietary Supplement: symbiotic, Dietary Supplement: whey proteinThis group received dietary guidance, symbiotic and whey protein intervention for 12 weeks |
| whey protein intervention | Experimental | Dietary Supplement: whey protein, Dietary Supplement: symbiotic placeboThis group received dietary guidance and whey protein intervention for 12 weeks |
| control | Placebo comparator | Dietary Supplement: symbiotic placebo, Dietary Supplement: whey protein placeboThis group received dietary guidance and maltodextrin for 12 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 and older
- Can cooperate with the measurement and questionnaire survey
- Meets Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria for sarcopenia
- Obtain informed consent to participate in this study
Key exclusion criteria (5 listed)
- Severe complications
- Suffers from neuromuscular related diseases
- Immobility
- Have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks
- Implants of electronic devices or metal objects in the body
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 |
|---|---|---|
| symbioticThe intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification. | Dietary supplement | symbiotic and whey protein intervention |
| whey proteinThe intervention is made up of whey protein supplements (20g/d) and dietary pattern modification. | Dietary supplement | symbiotic and whey protein intervention, whey protein intervention |
| symbiotic placeboThe intervention is made up of maltodextrin (20g/d) and dietary pattern modification. | Dietary supplement | control, whey protein intervention |
| whey protein placeboThe intervention is made up of maltodextrin (20g/d) and dietary pattern modification. | Dietary supplement | control |
Primary outcome
Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks
Time frame: 12 weeks
Defined as muscle mass (Unit: kg/m2)
Change from Baseline of grip strength at 12 weeks
Time frame: 12 weeks
Defined as muscle strength (Unit: kg)
5 secondary outcomes
Change from Baseline of Short Physical Performance Battery score at 12 weeks
Time frame: 12 weeks
Change from Baseline of gait speed at 12 weeks
Time frame: 12 weeks
Change from Baseline of gut microbiota composition at 12 weeks
Time frame: 12 weeks
Change from Baseline of inflammation status at 12 weeks
Time frame: 12 weeks
Change from Baseline of microbiota-derived metabolites at 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symbiotic and whey protein in people with Sarcopenia, run by Peking Union Medical College Hospital 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Yu, MD (+8613801130457, yuk1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks (time frame: 12 weeks). The study lists 2 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 22 Apr 2024.