Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

Not Applicable

Completed

• Conditions: Sarcopenia

• Registration Number: NCT05848960
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-08
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	6 months	Changes in left ventricular ejection fraction
Muscle mass	6 months	Changes in percent of muscle mass

Secondary Outcome Measures

Name	Time	Method
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)
Phase angle	6 months	Changes in phase angle using bioimpedance
Fat mass	6 months	Changes in fat mass using bioimpedance and echography
Albumin	6 months	Changes in serum albumin levels (g/l)
Preallbumin	6 months	Changes in serum prealbumin levels (mg/dl)

Trial Locations

Locations (1)

IMIBIC; 🇪🇸 Cordoba, Spain