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Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement
All participants will receive general counseling, education about MedDiet and vitamin D supplementation in order to reach levels of sufficiency (25OH vitamin D>30 ng/dL) for avoiding confounding results. Participants (n=50) will be randomly allocated to MedDiet or MedDiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ONS), 2 ONS per da). Participants will be evaluated at baseline, 12 and 24 weeks after nutritional support
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet | Active Comparator | Mediterranean diet |
|
| Mediterranean diet plus hypercaloric, hyperproteic oral supplement | Experimental | Mediterranean diet plus hypercaloric, hyperproteic oral supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypercaloric, hyperproteic oral supplement | Dietary Supplement | 2 supplements per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | Changes in percent of muscle mass | 6 months |
| Left ventricular ejection fraction | Changes in left ventricular ejection fraction | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pro-BNP | Changes in pro-BNP | 6 months |
| Fat mass | Changes in fat mass using bioimpedance and echography | 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 |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Mediterranean diet | Other | Mediterranean diet |
|
| Phase angle | Changes in phase angle using bioimpedance | 6 months |
| Albumin | Changes in serum albumin levels (g/l) | 6 months |
| Preallbumin | Changes in serum prealbumin levels (mg/dl) | 6 months |
| Transferrin | Changes in serum transferrin levels (mg/dl) | 6 months |
| CRP | Changes in CRP levels (g/l) | 6 months |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |