Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

NCT ID: NCT05848960

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-07-30

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

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mediterranean diet

Mediterranean diet

Group Type: ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type: OTHER

Mediterranean diet

Mediterranean diet plus hypercaloric, hyperproteic oral supplement

Mediterranean diet plus hypercaloric, hyperproteic oral supplement

Group Type: EXPERIMENTAL

Hypercaloric, hyperproteic oral supplement

Intervention Type: DIETARY_SUPPLEMENT

2 supplements per day

Mediterranean diet

Intervention Type: OTHER

Mediterranean diet

Interventions

Hypercaloric, hyperproteic oral supplement

2 supplements per day

Intervention Type: DIETARY_SUPPLEMENT

Mediterranean diet

Mediterranean diet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IMIBIC

Córdoba, Cordoba, Spain

Countries

Spain

Other Identifiers

Heart failure sarcopenia 1

Identifier Type: -

Identifier Source: org_study_id