Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT04738994
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Support for Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pro-inflammatory cytokine interleukin 6 (IL-6)', 'timeFrame': 'Baseline (T0) and day 15 (T1)', 'description': 'Change in IL-6 \\[Time Frame: after 15 days (T1) from baseline (T0)\\]'}], 'secondaryOutcomes': [{'measure': 'Pro-inflammatory cytokine interleukin 1beta (IL-1β)', 'timeFrame': 'Baseline (T0) and day 15 (T1)', 'description': 'Change in IL-1β \\[Time Frame: after 15 days (T1) from baseline (T0)\\]'}, {'measure': 'Tumor Necrosis Factor (TNF)', 'timeFrame': 'Baseline (T0) and day 15 (T1)', 'description': 'Change in TNF \\[Time Frame: after 15 days (T1) from baseline (T0)\\]'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'Baseline (T0) and day 15 (T1)', 'description': 'Change in CRP \\[Time Frame: after 15 days (T1) from baseline (T0)\\]'}, {'measure': 'Anti- inflammatory cytokine interleukin 10 (IL-10)', 'timeFrame': 'Baseline (T0) and day 15 (T1)', 'description': 'Change in IL-10 \\[Time Frame: after 15 days (T1) from baseline (T0)\\]'}, {'measure': 'Gut Microbiota (GM)', 'timeFrame': 'Baseline (T0) and day 15 (T1)', 'description': 'Change in GM \\[Time Frame: after 15 days (T1) from baseline (T0)\\]'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['whey protein', 'gut microbiota', 'interleukin 6', 'cardiac rehabilitation', 'nutritional supplement', 'inflammatory status'], 'conditions': ['Cardiac Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '21167685', 'type': 'BACKGROUND', 'citation': 'de Aguilar-Nascimento JE, Prado Silveira BR, Dock-Nascimento DB. Early enteral nutrition with whey protein or casein in elderly patients with acute ischemic stroke: a double-blind randomized trial. Nutrition. 2011 Apr;27(4):440-4. doi: 10.1016/j.nut.2010.02.013. Epub 2010 Dec 16.'}, {'pmid': '22857881', 'type': 'BACKGROUND', 'citation': 'Sugawara K, Takahashi H, Kashiwagura T, Yamada K, Yanagida S, Homma M, Dairiki K, Sasaki H, Kawagoshi A, Satake M, Shioya T. Effect of anti-inflammatory supplementation with whey peptide and exercise therapy in patients with COPD. Respir Med. 2012 Nov;106(11):1526-34. doi: 10.1016/j.rmed.2012.07.001. Epub 2012 Aug 3.'}, {'pmid': '25671415', 'type': 'BACKGROUND', 'citation': 'Zhou LM, Xu JY, Rao CP, Han S, Wan Z, Qin LQ. Effect of whey supplementation on circulating C-reactive protein: a meta-analysis of randomized controlled trials. Nutrients. 2015 Feb 9;7(2):1131-43. doi: 10.3390/nu7021131.'}, {'pmid': '27150497', 'type': 'BACKGROUND', 'citation': 'Fekete AA, Givens DI, Lovegrove JA. Can milk proteins be a useful tool in the management of cardiometabolic health? An updated review of human intervention trials. Proc Nutr Soc. 2016 Aug;75(3):328-41. doi: 10.1017/S0029665116000264. Epub 2016 May 6.'}, {'pmid': '20521985', 'type': 'BACKGROUND', 'citation': 'Laviolette L, Lands LC, Dauletbaev N, Saey D, Milot J, Provencher S, LeBlanc P, Maltais F. Combined effect of dietary supplementation with pressurized whey and exercise training in chronic obstructive pulmonary disease: a randomized, controlled, double-blind pilot study. J Med Food. 2010 Jun;13(3):589-98. doi: 10.1089/jmf.2009.0142.'}, {'pmid': '23360676', 'type': 'BACKGROUND', 'citation': 'Kerasioti E, Stagos D, Jamurtas A, Kiskini A, Koutedakis Y, Goutzourelas N, Pournaras S, Tsatsakis AM, Kouretas D. Anti-inflammatory effects of a special carbohydrate-whey protein cake after exhaustive cycling in humans. Food Chem Toxicol. 2013 Nov;61:42-6. doi: 10.1016/j.fct.2013.01.023. Epub 2013 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized trial the primary outcome is to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 6 (IL-6).\n\nHypothesis: Secondary outcomes are to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 1β (IL-1 β), tumor necrosis factor and C Reactive Protein (CRP); may increase anti-inflammatory interleukin 10 (IL-10) plasma concentrations and may change Gut Microbiota (GM) composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission for cardiac rehabilitation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient unable to eat orally\n* Eating disorders\n* Indication to Levodopa therapy\n* Gastrointestinal malignant diseases\n* Known kidney failure\n* Known liver failure\n* Previous antibiotic therapy\n* Refusal'}, 'identificationModule': {'nctId': 'NCT04738994', 'briefTitle': 'Nutritional Support for Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program', 'orgStudyIdInfo': {'id': 'wheyprotein1_FDG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'whey protein-enriched nutritional supplement', 'description': 'Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water', 'interventionNames': ['Dietary Supplement: whey protein-enriched nutritional supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard hospital diet', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'whey protein-enriched nutritional supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water', 'armGroupLabels': ['whey protein-enriched nutritional supplement']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Standard hospital diet', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50143', 'city': 'Florence', 'country': 'Italy', 'facility': 'Fondazione Don Carlo Gnocchi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Chiara F Gheri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Don Carlo Gnocchi Onlus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, {'name': 'University of Florence', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}