Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-26 @ 11:09 AM
Study NCT ID:
NCT03926806
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight management', 'timeFrame': '12 weeks', 'description': 'Change of body weight after dietary intervention'}, {'measure': 'Glycemic control', 'timeFrame': '12 weeks', 'description': 'Change of fasting plasma glucose after dietary intervention'}], 'secondaryOutcomes': [{'measure': 'Change of ghrelin response', 'timeFrame': '12 weeks', 'description': 'Change of ghrelin after the 12 weeks dietary intervention'}, {'measure': 'Change of GLP-1 response', 'timeFrame': '12 weeks', 'description': 'Change of GLP-1 after the 12 weeks dietary intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['yoghurt', 'vitamins B', 'body weight', 'glycemic control'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '27332081', 'type': 'BACKGROUND', 'citation': 'Panahi S, Tremblay A. The Potential Role of Yogurt in Weight Management and Prevention of Type 2 Diabetes. J Am Coll Nutr. 2016 Nov-Dec;35(8):717-731. doi: 10.1080/07315724.2015.1102103. Epub 2016 Jun 22.'}, {'pmid': '24484939', 'type': 'BACKGROUND', 'citation': 'Kaur B, Henry J. Micronutrient status in type 2 diabetes: a review. Adv Food Nutr Res. 2014;71:55-100. doi: 10.1016/B978-0-12-800270-4.00002-X.'}, {'pmid': '23591152', 'type': 'BACKGROUND', 'citation': 'El Khoury D, Brown P, Smith G, Berengut S, Panahi S, Kubant R, Anderson GH. Increasing the protein to carbohydrate ratio in yogurts consumed as a snack reduces post-consumption glycemia independent of insulin. Clin Nutr. 2014 Feb;33(1):29-38. doi: 10.1016/j.clnu.2013.03.010. Epub 2013 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The study investigates the effects of consumption of yoghurt enriched with vitamins B compared to plain yoghurt, on body weight management and glycemic control of overweight/obese T2DM patients. It also investigates the effect of plain yoghurt consumption on gut hormones response of T2DM patients.', 'detailedDescription': 'In a large number of epidemiological studies, low-fat dairy consumption has been associated with lower risk of T2DM. However, the number of randomized clinical trials which examine the impact of yoghurt consumption on glycemic control and body weight management of T2DM patients is small and include yoghurts fortified with vitamin D or probiotics. According to our knowledge, fortification of yoghurt with other classes of vitamins beyond vitamin D has not been examined. Vitamins of B-complex hold key-role in energy metabolism. In the state of diabetes mellitus, the requirements for this vitamin class may be higher because of their water solubility and increased excretion. Two groups of patients participated in the study. One group received yoghurt enriched with vitamins B and one group received isocaloric plain yoghurt. In addition, in order to investigate the effect of plain yoghurt on gut hormones, responses to a mixed meal tolerance test were evaluated in the beggining and the end of the dietary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 27-36\n* HbA1C \\< 8.5%\n* Constant body weight and dietary habits for the last 3 months\n* Stable dose of oral medication for at least 3 months\n* Diagnosed with T2DM for more than 1 year\n\nExclusion Criteria:\n\n* History of cardiovascular, gastrointestinal, renal and endocrinological diseases\n* Treatment for weight reduction\n* Lactose intolerance\n* Allergies to milk and dairy products\n* Alcohol consumption (\\> 2 drinks per day)\n* Intake of supplements\n* Receiving insulin'}, 'identificationModule': {'nctId': 'NCT03926806', 'briefTitle': 'Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Harokopio University'}, 'officialTitle': 'Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients', 'orgStudyIdInfo': {'id': '1354.18-11-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plain yoghurt', 'description': '2x200g plain yoghurt/day for 12 weeks', 'interventionNames': ['Other: Plain yoghurt']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin B yoghurt', 'description': '2x200g yoghurt enriched with vitamins B for 12 weeks', 'interventionNames': ['Other: Vitamin B yoghurt']}], 'interventions': [{'name': 'Plain yoghurt', 'type': 'OTHER', 'otherNames': ['Conventional yoghurt'], 'description': 'cups of 200 g yoghurt', 'armGroupLabels': ['Plain yoghurt']}, {'name': 'Vitamin B yoghurt', 'type': 'OTHER', 'description': 'cups of 200 g yoghurt', 'armGroupLabels': ['Vitamin B yoghurt']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amalia Yanni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harokopio University'}, {'name': 'Nikolaos Tentolouris', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}, {'name': 'Vaios Karathanos', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harokopio University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harokopio University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research and Teaching Associate-Staff', 'investigatorFullName': 'Amalia Yanni', 'investigatorAffiliation': 'Harokopio University'}}}}