Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:57 AM
Study NCT ID:
NCT07462858
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tuna Based Nuggets and Ischemic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067329', 'term': 'Obesity, Metabolically Benign'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'there was no masking because participants were counselled for that they were receiving in dietary intervention and researcher either as dietician had to guide participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'in this model screened participants are randomly assigned to two groups at a same time. one treatment group and one is placebo group. treatment group takes nutritional interventions for three month. at the end both groups were compared for analysis and conclusion was drawn.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin (IL-6)', 'timeFrame': '3months', 'description': 'anti inflammatory marker'}, {'measure': 'C- Reactive Protein(CRP)', 'timeFrame': '3months', 'description': 'anti-inflammatory marker'}, {'measure': 'Cardiac Kinase(CK)', 'timeFrame': '3months', 'description': 'Cardiac enzymes'}], 'secondaryOutcomes': [{'measure': 'BMI(Body Mass Index)', 'timeFrame': '3 months', 'description': 'Anthropometric measurements'}, {'measure': 'Fasting Basal Sugar', 'timeFrame': '3-months', 'description': 'levels below 100mg/dL in samples are considered normal'}, {'measure': 'Total Cholesterol', 'timeFrame': '3-months', 'description': 'In blood sample normal value should be less than 200mg/dL. Total cholesterol: \\<200mg/dL'}, {'measure': 'Triglycerides', 'timeFrame': '3-months', 'description': 'In triglycerides, blood test should be between 10-150mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Cardiomyopathy', 'Obesity, Metabolically Benign']}, 'referencesModule': {'references': [{'pmid': '36238760', 'type': 'RESULT', 'citation': 'Luo Y, He X, Hu L, Zhao J, Su K, Lei Y, Li Y. The Relationship Between Plasma Selenium, Antioxidant Status, Inflammatory Responses and Ischemic Cardiomyopathy: A Case-Control Study Based on Matched Propensity Scores. J Inflamm Res. 2022 Oct 10;15:5757-5765. doi: 10.2147/JIR.S383476. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'the study is to evaluate the effect of tuna-based nuggets on cardiomyopathy patients. participants were recruited from cardiology hospital and selenium dose in form of nuggets were given to patients that were enrolled in treatment group for three months. the finding were improved biomarker level(IL-6) and lab investigations.', 'detailedDescription': 'this study aims to assess the effect of a nutritional interventional with tuna based nugget with diet plan on BMI, dietary habits and anti-inflammatory level in blood. as tuna is taken as best source of selenium that is effective for cardiomyopathy patients. Eligible participants received dietary counselling with one slice of fish nugget daily foe 12 weeks. anthropometric measurements, biochemical and anti-inflammatory test was done before and after completion of study. Out of 120 participants, 60 were enrolled as treatment and other 60 as control group with no intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Diagnosed ICMP patients post-myocardial infarction\n* Type 2 diabetic patients\n* Age range between 35 to 70 years\n* Overweight individuals (BMI \\> 25 kg/m²)\n* Presence of dyslipidemia Exclusion Criteria\n* Chronic renal failure\n* Hepatic failure\n* Connective tissue disorders\n* Respiratory failure\n* Hypertrophic cardiomyopathy\n* Heart failure with preserved ejection fraction (EF \\> 40%)'}, 'identificationModule': {'nctId': 'NCT07462858', 'acronym': 'ICMP', 'briefTitle': 'Tuna Based Nuggets and Ischemic Cardiomyopathy', 'organization': {'class': 'NETWORK', 'fullName': 'University of Lahore Hospital (ULH)'}, 'officialTitle': 'Development and Efficacy Assessment of Tuna-based (Thunnus Albacares) Nuggets on Cardio-metabolic Risk Factors in Ischemic Cardiomyopathy Patients', 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tuna fish nuggets', 'description': 'tuna fish nugget having 5g weight each for 12 weeks on daily basis. one nugget per day constitute 55micro gram selenium', 'interventionNames': ['Dietary Supplement: tuna based nuggets']}], 'interventions': [{'name': 'tuna based nuggets', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['non'], 'description': 'tuna based nugget(5g) having recommended selenium amount and herbs without frying process.', 'armGroupLabels': ['tuna fish nuggets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'country': 'Pakistan', 'facility': 'punjab institute of cardiology, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore Hospital (ULH)', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Wajeeha Bashir Baig', 'investigatorAffiliation': 'University of Lahore Hospital (ULH)'}}}}