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Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet | Active Comparator | Mediterranean diet and physical exercise |
|
| Standard hypercaloric hyperproteic Oral supplement | Experimental | Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise |
|
| Protein module | Experimental | Protein module (10g/day) plus Mediterranean diet and physical exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Other | Mediterranean diet recommendations and daily physical exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | Changes in muscle mass | 6 months |
| Functionality | Changes in functionality determined by the up and go test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Albumin | Changes in serum albumin levels (g/dl) | 6 months |
| C-RP | Changes in serum C-RP (g/dl) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMIBIC | Córdoba | Cordoba | 14004 | Spain |
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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 |
|---|---|
| D038441 | Diet, Mediterranean |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Hypercaloric, hyperproteic oral nutritional supplement | Dietary Supplement | Hypercaloric, hyperproteic oral supplement combined with Mediterranean diet recommendations (2 per day) and daily physical exercise |
|
| Protein module | Dietary Supplement | Protein module (10g/day) combined with Mediterranean diet recommendations and daily physical exercise |
|
| Vitamin D supplementation | Combination Product | Calcifediol supplement administered orally in order to reach sufficiency levels (30 ng/ml) |
|
| Physical exercise | Combination Product | Physical exercise adapted to patients with heart failure (Cardiac rehabilitation) |
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |