Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Hypercaloric, hyperproteic oral supplement; Other: Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05848960

Heart failure sarcopenia 1

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Mediterranean diet

Active Comparator group

Description:

Mediterranean diet

Treatment:

Other: Mediterranean diet

Mediterranean diet plus hypercaloric, hyperproteic oral supplement

Experimental group

Description:

Mediterranean diet plus hypercaloric, hyperproteic oral supplement

Treatment:

Other: Mediterranean diet

Dietary Supplement: Hypercaloric, hyperproteic oral supplement