Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

May 5, 2025 updated by: Maimónides Biomedical Research Institute of Córdoba

Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cordoba, Spain, 14004
        • IMIBIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mediterranean diet
Other: Mediterranean diet
Mediterranean diet
Experimental: Mediterranean diet plus hypercaloric, hyperproteic oral supplement
Other: Mediterranean diet
Mediterranean diet
Dietary supplement: Hypercaloric, hyperproteic oral supplement
2 supplements per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: 6 months
Changes in percent of muscle mass
6 months
Left ventricular ejection fraction
Time Frame: 6 months
Changes in left ventricular ejection fraction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pro-BNP
Time Frame: 6 months
Changes in pro-BNP
6 months
Fat mass
Time Frame: 6 months
Changes in fat mass using bioimpedance and echography
6 months
Phase angle
Time Frame: 6 months
Changes in phase angle using bioimpedance
6 months
Albumin
Time Frame: 6 months
Changes in serum albumin levels (g/l)
6 months
Preallbumin
Time Frame: 6 months
Changes in serum prealbumin levels (mg/dl)
6 months
Transferrin
Time Frame: 6 months
Changes in serum transferrin levels (mg/dl)
6 months
CRP
Time Frame: 6 months
Changes in CRP levels (g/l)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heart failure sarcopenia 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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