Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 3:53 PM
Study NCT ID:
NCT05848960
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2023-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia
Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Organization:
Study Overview
Official Title:
Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: