Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT04988594
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in parameters associated with glucose homeostasis', 'timeFrame': 'Baseline and week 12', 'description': 'At time 0 and after 12 weeks of intervention and follow-up, it was determined in mg/dL following the protocols established for: HDL-c (high-density lipoprotein cholesterol), LDL-c (low-density lipoprotein cholesterol), triglycerides and glucose. Likewise, glycosylated hemoglobin (HbA1c in percentage) was determined.'}], 'secondaryOutcomes': [{'measure': 'Changes in inflammatory parameters', 'timeFrame': 'Baseline and week 12', 'description': 'At time 0 and after 12 weeks of intervention and follow-up, the high sensitivity C-reactive protein (hs-CRP) was determined in plasma in mg/dL. Likewise, interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-a) in ng/mL.'}, {'measure': 'Changes in oxidative stress parameters', 'timeFrame': 'Baseline and week 12', 'description': 'Superoxide dismutase, glutathione peroxidase and catalase (SOD, GPx, CAT, respectively) will be measured in U/mg by spectrophotometry at time 0 and after 12 weeks of intervention and follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['probiotics', 'glucose homeostasis'], 'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to analyze the effects of the consumption of yogurt with concentrated and lyophilized probiotic cultures on the parameters associated with glucose homeostasis, inflammation and oxidative stress in patients with Type 2 Diabetes Mellitus (T2DM).', 'detailedDescription': 'After being informed about the study and the potential risks, all patients who gave their written informed consent underwent a screening period of 1 week to determine their eligibility to participate in the study. At week 0, patients who met the eligibility requirements were randomized in a double-blind manner (participant and investigator) to the American Diabetes Association (ADA) diet + yogurt with premium probiotics (300 g/d) or ADA diet + conventional yogurt (300 g/d) or ADA diet without fermented dairy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with T2DM diagnosed at least one year ago.\n* That they are outpatients.\n* Between 25 and 65 years old.\n\nExclusion Criteria:\n\n* Smoking patients.\n* Lactose intolerance.\n* Pregnancy or breastfeeding.\n* Presence of kidney, liver, immunodeficiency, inflammatory bowel disease or thyroid disorder.\n* Use of insulin, estrogen, progesterone or diuretic injections.\n* Consumption of probiotic supplements two months before the start of the study'}, 'identificationModule': {'nctId': 'NCT04988594', 'briefTitle': 'Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Medical Sciences, Clinical Hospital'}, 'officialTitle': 'A 12-weeks Double Blind Trial of Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'FMSParaguay'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premium probiotic yogurt', 'description': 'Participants receive 300 g/d of yogurt with concentrated and freeze-dried probiotic cultures for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA).', 'interventionNames': ['Dietary Supplement: Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional yogurt', 'description': 'Participants receive 300 g/d of conventional yogurt for 12 weeks. Also, the nutritional recommendations of the American Diabetes Association (ADA).', 'interventionNames': ['Dietary Supplement: Lactobacillus bulgaricus and Streptococcus thermophillus']}, {'type': 'EXPERIMENTAL', 'label': 'no fermented dairy', 'description': 'Participants followed the American Diabetes Association (ADA) recommendations without including fermented dairy.', 'interventionNames': ['Dietary Supplement: No culture']}], 'interventions': [{'name': 'Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cultures containing 3.7 × 10 \\^ 9 CFU/mg', 'armGroupLabels': ['Premium probiotic yogurt']}, {'name': 'Lactobacillus bulgaricus and Streptococcus thermophillus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cultures containing 3.7 × 10 \\^ 6 CFU/mg', 'armGroupLabels': ['Conventional yogurt']}, {'name': 'No culture', 'type': 'DIETARY_SUPPLEMENT', 'description': 'No probiotic cultures', 'armGroupLabels': ['no fermented dairy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Instituto Maimonides de Investigacion Biomedica de Cordoba', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Pablo Perez Martinez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain'}, {'name': 'Maria Ruiz Diaz Narvaez, DN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medical Science, Paraguay'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Medical Sciences, Clinical Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Nutritionist', 'investigatorFullName': 'Maria Eugenia Ruiz Diaz Narvaez', 'investigatorAffiliation': 'Faculty of Medical Sciences, Clinical Hospital'}}}}