Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05848960
• Other study ID #: Heart failure sarcopenia 1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: April 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 30, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Sarcopenia

Intervention

Dietary Supplement:
• Hypercaloric, hyperproteic oral supplement
2 supplements per day

Other:
• Mediterranean diet
Mediterranean diet

Locations

Country	Name	City	State
Spain	IMIBIC	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Changes in percent of muscle mass	6 months
Primary	Left ventricular ejection fraction	Changes in left ventricular ejection fraction	6 months
Secondary	pro-BNP	Changes in pro-BNP	6 months
Secondary	Fat mass	Changes in fat mass using bioimpedance and echography	6 months
Secondary	Phase angle	Changes in phase angle using bioimpedance	6 months
Secondary	Albumin	Changes in serum albumin levels (g/l)	6 months
Secondary	Preallbumin	Changes in serum prealbumin levels (mg/dl)	6 months
Secondary	Transferrin	Changes in serum transferrin levels (mg/dl)	6 months
Secondary	CRP	Changes in CRP levels (g/l)	6 months