Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-05 @ 7:02 AM
Study NCT ID:
NCT02407769
Status:
UNKNOWN
Last Update Posted:
2015-04-03
First Post:
2015-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000596', 'term': 'Amino Acids'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Composition', 'timeFrame': 'Basal and 30 and 60 days after intervention.', 'description': 'The body composition will be measured with air displacement pletismografy through Bodpod the results will be expressed in percentaje of fat mass and fat free mass.'}], 'secondaryOutcomes': [{'measure': 'Change in Mid arm muscle area', 'timeFrame': 'Basal and 30 and 60 days after intervention.', 'description': 'Estimation of muscle area of the no dominant arm using the formula \\[(MAMA - (π x PT))2 / 4 π \\]\n\n\\- 10 in men and -6.5 in women, the result is expressed in cm2.'}, {'measure': 'Change in Quality of life', 'timeFrame': 'Basal and 30 and 60 days after intervention.', 'description': 'It will be measured by the questionnaire SF-36 that is a generic scale providing a health profile and is applicable for both, patients and general population; the results that the 36 questions divided in 8 dimensions. The patients answers will be transformed to a numeric scale: since 0 (worst) to 100 (better)'}, {'measure': 'Change in Fase angle.', 'timeFrame': 'Basal and 30 and 60 days after intervention.', 'description': 'vectorial sum of the resistance and reactance result in the impedance, and the angle that is formed is called the fase angle; this is obtain through a impedanciometre, the measure is expressed in grades.'}, {'measure': 'Change in Handgrip strength.', 'timeFrame': 'Basal and 30 and 60 days after intervention.', 'description': 'Handgrip strength of the no dominant hand will be measured by a hand dynamometer in kilograms/Force'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver transplantation', 'Liver cirrhosis', 'Branched chain amino acids', 'Late evening supplementation', 'Nutritional status'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)', 'detailedDescription': 'Clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle \\< 5.4°, subjective global assessment B or C and/or handgrip strength \\< 30 in men and \\< 20 in women). The investigators make them body composition assessment (weight, height, body mass index \\[BMI\\], mean arm circumference \\[MAC\\], muscle arm area \\[MAA\\], tricipital skinfold, Dual X ray absorptiometry \\[fat mass and fat free mass\\]) and handgrip strength at beginning and after 30 days of nocturne supplementation with BCAA and standardized diet (35-40 Kcal, 55% carbohydrates, 25% lipids and 20% proteins).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on waiting list for liver transplantation.\n* Diagnosis of undernutrition.\n\nExclusion Criteria:\n\n* Hepatorrenal syndrome.\n* Hepatopulmonar syndrome\n* Diabetes\n* Overweight'}, 'identificationModule': {'nctId': 'NCT02407769', 'briefTitle': 'Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Guanajuato'}, 'officialTitle': 'Effect of a Late Evening Supplementation With Branched Chain Amino Acids on the Nutritional Status in Patients on the Waiting List for Liver Transplantation', 'orgStudyIdInfo': {'id': 'GAS-1103-13/14-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Branched chain amino acids', 'description': 'The patients will drink a Enterex Hepatic bag (500 Kcal, 18.6g of proteins of which 8.63g are branched chain amino acids, 71.7g of carbohydrates and 15.4g of lipids) during the late evening (after 19:00 hours) daily by two months.', 'interventionNames': ['Dietary Supplement: Late evening supplementation with branched chain amino acids']}, {'type': 'SHAM_COMPARATOR', 'label': 'Late evening snack', 'description': 'The patients will eat a snack with similar nutrimental facts that food supplement (480 Kcal, 19g of proteins and they were based in casein and vegetable proteins; 17g of lipids and 63g of carbohydrates) during the late evening (after 19:00 hours) daily by two months.', 'interventionNames': ['Dietary Supplement: Late evening supplementation with branched chain amino acids']}], 'interventions': [{'name': 'Late evening supplementation with branched chain amino acids', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Enterex hepatic'], 'description': 'The patients will drink a Enterex Hepatic bag (500 Kcal, 18.6g of proteins of which 8.63g are branched chain amino acids, 71.7g of carbohydrates and 15.4g of lipids) during late evening (after 19:00 hours) in comparison with the late evening snack group which will eat a snack based in food with the next nutrimental facts (480 Kcal, 19g of proteins based in casein and vegetables sources, 17g of lipids and 63g of carbohydrates) during the same schedule that intervention group.', 'armGroupLabels': ['Branched chain amino acids', 'Late evening snack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Niko Alain Cruz Sancén', 'role': 'CONTACT', 'email': 'nick_07a@hotmail.com', 'phone': '524661043578'}, {'name': 'Elisa Gómez Reyes', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Graciela Castro Narro', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Niko Alain Cruz Sancén', 'role': 'CONTACT', 'email': 'nick_07a@hotmail.com', 'phone': '524661043578'}], 'overallOfficials': [{'name': 'Niko Alain Cruz Sancén', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Guanajuato'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Guanajuato', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dietitian', 'investigatorFullName': 'Niko Alain Cruz Sancén', 'investigatorAffiliation': 'Universidad de Guanajuato'}}}}