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OpenTrials
Completed

NCT Number: NCT05848960

Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

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

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Key information

Conditions

Sarcopenia Atrophy Cardiovascular Diseases Heart Diseases Heart Failure Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMIBIC

Córdoba, Cordoba, 14004, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypercaloric, hyperproteic oral supplement

Dietary Supplement

2 supplements per day

Mediterranean Diet

Other

Mediterranean diet

Primary outcomes

  1. Muscle mass

    Time frame: 6 months

    Changes in percent of muscle mass

  2. Left ventricular ejection fraction

    Time frame: 6 months

    Changes in left ventricular ejection fraction

Secondary outcomes

  1. pro-BNP

    Time frame: 6 months

    Changes in pro-BNP

  2. Fat mass

    Time frame: 6 months

    Changes in fat mass using bioimpedance and echography

  3. Phase angle

    Time frame: 6 months

    Changes in phase angle using bioimpedance

  4. Albumin

    Time frame: 6 months

    Changes in serum albumin levels (g/l)

  5. Preallbumin

    Time frame: 6 months

    Changes in serum prealbumin levels (mg/dl)

  6. Transferrin

    Time frame: 6 months

    Changes in serum transferrin levels (mg/dl)

  7. CRP

    Time frame: 6 months

    Changes in CRP levels (g/l)

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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