Sarcopenia
Conditions
Keywords
Heart failure, Sarcopenia, Nutritional support
Brief summary
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
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
Interventions
DIETARY_SUPPLEMENTHypercaloric, hyperproteic oral supplement
2 supplements per day
OTHERMediterranean diet
Mediterranean diet
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | 6 months | Changes in percent of muscle mass |
| Left ventricular ejection fraction | 6 months | Changes in left ventricular ejection fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase angle | 6 months | Changes in phase angle using bioimpedance |
| Albumin | 6 months | Changes in serum albumin levels (g/l) |
| pro-BNP | 6 months | Changes in pro-BNP |
| Transferrin | 6 months | Changes in serum transferrin levels (mg/dl) |
| CRP | 6 months | Changes in CRP levels (g/l) |
| Preallbumin | 6 months | Changes in serum prealbumin levels (mg/dl) |
| Fat mass | 6 months | Changes in fat mass using bioimpedance and echography |
Countries
Spain
Outcome results
None listed