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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symbiotic and whey protein intervention | Experimental | This group received dietary guidance, symbiotic and whey protein intervention for 12 weeks |
|
| whey protein intervention | Experimental | This group received dietary guidance and whey protein intervention for 12 weeks |
|
| control | Placebo Comparator | This group received dietary guidance and maltodextrin for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| symbiotic | Dietary Supplement | The intervention is made up of multiple probiotics and prebiotics (20g/d) and dietary pattern modification. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks | Defined as muscle mass (Unit: kg/m2) | 12 weeks |
| Change from Baseline of grip strength at 12 weeks | Defined as muscle strength (Unit: kg) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Change from Baseline of gait speed at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Yu, MD | Contact | +8613801130457 | yuk1997@sina.com | |
| Jiayu Guo, PhD | Contact | +8613719283691 | guojy_7@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| whey protein | Dietary Supplement | The intervention is made up of whey protein supplements (20g/d) and dietary pattern modification. |
|
| symbiotic placebo | Dietary Supplement | The intervention is made up of maltodextrin (20g/d) and dietary pattern modification. |
|
| whey protein placebo | Dietary Supplement | The intervention is made up of maltodextrin (20g/d) and dietary pattern modification. |
|
Defined as gait speed (Unit: m/s)
| 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). | 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). | 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. | 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |