Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02180035
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2014-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2015-05-22', 'unreleaseDateUnknown': True}, {'resetDate': '2015-06-15', 'releaseDate': '2015-05-23'}], 'estimatedResultsFirstSubmitDate': '2015-05-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seric lipid levels', 'timeFrame': 'Baseline, Week 24', 'description': 'Changes from baseline in total cholesterol, triglycerides, HDL-C and LDL-C.'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': 'Baseline, Week 24', 'description': 'Changes from baseline in fasting blood glucose.'}, {'measure': 'Gastrointestinal symptoms', 'timeFrame': 'Baseline, Week 24', 'description': 'Assessment of the presence of gastrointestinal symptoms (nausea and/or vomiting, dyspepsia, heartburn, diarrhea, flatulence and constipation), associated or not with antiretrorival therapy, before and after intervention to verify their effectiveness in reducing these symptoms.'}, {'measure': 'Adherence to the nutritional intervention and nutritional appointments', 'timeFrame': 'Baseline, Week 24', 'description': "Assessment of dietary intake modification after intervention and patient's return to nutritional appointments."}, {'measure': 'Body composition', 'timeFrame': 'Baseline, Week 24', 'description': 'Changes from baseline in total body fat percentage, percentage of fat in the trunk, percentage of fat in the arms, percentage of fat in the legs and lean body mass percentage.'}, {'measure': 'Anthropometric measures', 'timeFrame': 'Baseline, Week 24', 'description': 'Changes from baseline in weight, waist circumference, abdominal circumference, waist-to-hip ratio and Body Mass Index (BMI).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diet therapy', 'symbiotic', 'dyslipidemia', 'gastrointestinal symptoms', 'body composition', 'adherence', 'HIV', 'HAART'], 'conditions': ['Dietary Modification', 'Dyslipidemia', 'Signs and Symptoms, Digestive', 'HIV']}, 'referencesModule': {'references': [{'pmid': '22782126', 'type': 'BACKGROUND', 'citation': 'Falco M, Castro Ade C, Silveira EA. [Nutritional therapy in metabolic changes in individuals with HIV/AIDS]. Rev Saude Publica. 2012 Aug;46(4):737-46. doi: 10.1590/s0034-89102012005000050. Epub 2012 Jul 10. Portuguese.'}, {'pmid': '24228022', 'type': 'BACKGROUND', 'citation': 'Nery MW, Martelli CM, Silveira EA, de Sousa CA, Falco Mde O, de Castro Ade C, Esper JT, Souza LC, Turchi MD. Cardiovascular risk assessment: a comparison of the Framingham, PROCAM, and DAD equations in HIV-infected persons. ScientificWorldJournal. 2013 Oct 21;2013:969281. doi: 10.1155/2013/969281. eCollection 2013.'}, {'pmid': '27395330', 'type': 'DERIVED', 'citation': 'Santos ASEAC, Silveira EAD, Falco MO, Nery MW, Turchi MD. Effectiveness of nutritional treatment and synbiotic use on gastrointestinal symptoms reduction in HIV-infected patients: Randomized clinical trial. Clin Nutr. 2017 Jun;36(3):680-685. doi: 10.1016/j.clnu.2016.06.005. Epub 2016 Jun 23.'}], 'seeAlsoLinks': [{'url': 'http://189.28.128.100/nutricao/docs/geral/manual_clinico_alimentacao_nutricao_aids_hiv.pdf', 'label': 'Brazil Ministry of Health guidance on food and nutrition for patients with HIV'}]}, 'descriptionModule': {'briefSummary': 'To evaluate if nutritional treatment with nutritional supplementation of dietary fiber reduces cholesterol levels and triglycerides (dyslipidemia) in patients with HIV/AIDS receiving antiretroviral therapy (HAART).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected patients\n* Adults (≥ 19 years old)\n* On highly active antiretroviral therapy (HAART)\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Opportunistic disease'}, 'identificationModule': {'nctId': 'NCT02180035', 'acronym': 'PRECOR-NUT', 'briefTitle': 'Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico'}, 'officialTitle': 'Effect of Treatment Nutritional With Supplementation About Biochemical Profile and Anthropometry in Adult Patients With HIV/AIDS', 'orgStudyIdInfo': {'id': 'CNPq- 478741/2008-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symbiotic & Nutritional intervention', 'description': 'Symbiotic (dietary fibers + probiotic bacteria) 6g sachet twice daily for 6 months, dietary prescription and nutritional counseling', 'interventionNames': ['Dietary Supplement: Symbiotic', 'Behavioral: Nutritional intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin & Nutritional intervention', 'description': 'Maltodextrin (placebo for symbiotic) 6g sachet twice daily for 6 months, dietary intervention and nutritional counseling.', 'interventionNames': ['Dietary Supplement: Maltodextrin (placebo for symbiotic)', 'Behavioral: Nutritional intervention']}], 'interventions': [{'name': 'Symbiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': '6g sachet composition: Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophillus, Bifidobacterium lactis and fructooligosaccharides. Each patient was instructed to consume two sachets per day, one in the morning and another before bedtime, diluted in 100 ml of filtered or boiled water at room temperature. The dietary supplement should be taken every day for 6 months.', 'armGroupLabels': ['Symbiotic & Nutritional intervention']}, {'name': 'Maltodextrin (placebo for symbiotic)', 'type': 'DIETARY_SUPPLEMENT', 'description': '6g sachet of maltodextrin, a complex carbohydrate. Each patient was instructed to consume two sachets per day, one in the morning and another before bedtime, diluted in 100 ml of filtered or boiled water at room temperature. Placebo should be taken daily for 6 months.', 'armGroupLabels': ['Maltodextrin & Nutritional intervention']}, {'name': 'Nutritional intervention', 'type': 'BEHAVIORAL', 'description': 'Nutritional intervention consists of dietary prescription (nutritional eating plan) for healthy eating based on the Dietary Guidelines for the Brazilian Population and Clinical Manual on Food and Nutrition in HIV-infected Adults Care, both Brazil Ministry of Health guidelines, in addition to nutritional counseling for preexistent clinical conditions.', 'armGroupLabels': ['Maltodextrin & Nutritional intervention', 'Symbiotic & Nutritional intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74.605-020', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Outpatient Infectoparasitary Diseases, Hospital das Clinicas, Federal University of Goiás', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'overallOfficials': [{'name': 'Marianne O Falco, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Goiás'}, {'name': 'Erika A Silveira, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Goiás'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Effect of Treatment With Nutritional Eating Plan and Supplementation With Dietary Fibers in Adult Patients With HIV / AIDS', 'investigatorFullName': 'Marianne de Oliveira Falco', 'investigatorAffiliation': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-05-22', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2015-05-23', 'type': 'RELEASE'}, {'date': '2015-06-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Marianne de Oliveira Falco, Effect of Treatment With Nutritional Eating Plan and Supplementation With Dietary Fibers in Adult Patients With HIV / AIDS, Conselho Nacional de Desenvolvimento Científico e Tecnológico'}}}}