Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Hypercaloric, hyperproteic oral supplement
* Other: Mediterranean diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with a previous admission due to HF in the previous 12 months Moderate or severe LVEF Both sexs Age >18 years old. Exclusion Criteria: MDRD <15 ml/min End-stage liver disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mediterranean diet<br>Mediterranean diet | Other: Mediterranean diet<br>* Mediterranean diet<br>|
| Experimental: Mediterranean diet plus hypercaloric, hyperproteic oral supplement<br>Mediterranean diet plus hypercaloric, hyperproteic oral supplement | Dietary Supplement: Hypercaloric, hyperproteic oral supplement<br>* 2 supplements per day<br>Other: Mediterranean diet<br>* Mediterranean diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pro-BNP | Changes in pro-BNP | 6 months | 
| Fat mass | Changes in fat mass using bioimpedance and echography | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Sarcopenia, Nutritional support