Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia
Primary Purpose
Sarcopenia
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hypercaloric, hyperproteic oral supplement
Mediterranean diet
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia focused on measuring Heart failure, Sarcopenia, Nutritional support
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.
Sites / Locations
- IMIBIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mediterranean diet
Mediterranean diet plus hypercaloric, hyperproteic oral supplement
Arm Description
Mediterranean diet
Mediterranean diet plus hypercaloric, hyperproteic oral supplement
Outcomes
Primary Outcome Measures
Muscle mass
Changes in percent of muscle mass
Left ventricular ejection fraction
Changes in left ventricular ejection fraction
Secondary Outcome Measures
pro-BNP
Changes in pro-BNP
Fat mass
Changes in fat mass using bioimpedance and echography
Phase angle
Changes in phase angle using bioimpedance
Albumin
Changes in serum albumin levels (g/l)
Preallbumin
Changes in serum prealbumin levels (mg/dl)
Transferrin
Changes in serum transferrin levels (mg/dl)
CRP
Changes in CRP levels (g/l)
Full Information
NCT ID
NCT05848960
First Posted
April 17, 2023
Last Updated
May 8, 2023
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT05848960
Brief Title
Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia
Official Title
Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Heart failure, Sarcopenia, Nutritional support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mediterranean diet
Arm Type
Active Comparator
Arm Description
Mediterranean diet
Arm Title
Mediterranean diet plus hypercaloric, hyperproteic oral supplement
Arm Type
Experimental
Arm Description
Mediterranean diet plus hypercaloric, hyperproteic oral supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Hypercaloric, hyperproteic oral supplement
Intervention Description
2 supplements per day
Intervention Type
Other
Intervention Name(s)
Mediterranean diet
Intervention Description
Mediterranean diet
Primary Outcome Measure Information:
Title
Muscle mass
Description
Changes in percent of muscle mass
Time Frame
6 months
Title
Left ventricular ejection fraction
Description
Changes in left ventricular ejection fraction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
pro-BNP
Description
Changes in pro-BNP
Time Frame
6 months
Title
Fat mass
Description
Changes in fat mass using bioimpedance and echography
Time Frame
6 months
Title
Phase angle
Description
Changes in phase angle using bioimpedance
Time Frame
6 months
Title
Albumin
Description
Changes in serum albumin levels (g/l)
Time Frame
6 months
Title
Preallbumin
Description
Changes in serum prealbumin levels (mg/dl)
Time Frame
6 months
Title
Transferrin
Description
Changes in serum transferrin levels (mg/dl)
Time Frame
6 months
Title
CRP
Description
Changes in CRP levels (g/l)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
IMIBIC
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia
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