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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle mass', 'timeFrame': '6 months', 'description': 'Changes in percent of muscle mass'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': '6 months', 'description': 'Changes in left ventricular ejection fraction'}], 'secondaryOutcomes': [{'measure': 'pro-BNP', 'timeFrame': '6 months', 'description': 'Changes in pro-BNP'}, {'measure': 'Fat mass', 'timeFrame': '6 months', 'description': 'Changes in fat mass using bioimpedance and echography'}, {'measure': 'Phase angle', 'timeFrame': '6 months', 'description': 'Changes in phase angle using bioimpedance'}, {'measure': 'Albumin', 'timeFrame': '6 months', 'description': 'Changes in serum albumin levels (g/l)'}, {'measure': 'Preallbumin', 'timeFrame': '6 months', 'description': 'Changes in serum prealbumin levels (mg/dl)'}, {'measure': 'Transferrin', 'timeFrame': '6 months', 'description': 'Changes in serum transferrin levels (mg/dl)'}, {'measure': 'CRP', 'timeFrame': '6 months', 'description': 'Changes in CRP levels (g/l)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Sarcopenia', 'Nutritional support'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients with a previous admission due to HF in the previous 12 months\n* Moderate or severe LVEF\n* Both sexs\n* Age \\>18 years old.\n\nExclusion Criteria:\n\n* MDRD \\<15 ml/min\n* End-stage liver disease.'}, 'identificationModule': {'nctId': 'NCT05848960', 'briefTitle': 'Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia', 'orgStudyIdInfo': {'id': 'Heart failure sarcopenia 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean diet', 'description': 'Mediterranean diet', 'interventionNames': ['Other: Mediterranean diet']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean diet plus hypercaloric, hyperproteic oral supplement', 'description': 'Mediterranean diet plus hypercaloric, hyperproteic oral supplement', 'interventionNames': ['Dietary Supplement: Hypercaloric, hyperproteic oral supplement', 'Other: Mediterranean diet']}], 'interventions': [{'name': 'Hypercaloric, hyperproteic oral supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 supplements per day', 'armGroupLabels': ['Mediterranean diet plus hypercaloric, hyperproteic oral supplement']}, {'name': 'Mediterranean diet', 'type': 'OTHER', 'description': 'Mediterranean diet', 'armGroupLabels': ['Mediterranean diet', 'Mediterranean diet plus hypercaloric, hyperproteic oral supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'state': 'Cordoba', 'country': 'Spain', 'facility': 'IMIBIC', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}