Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-15 @ 5:30 PM
Study NCT ID:
NCT03037918
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants will be given a unique identifier, which will not disclose the treatment group. All biological samples will be labelled with only the unique identifier.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label, control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole body insulin sensitivity index', 'timeFrame': 'The change between pre- and post-high fat diet (assessed on days 21 and 28)', 'description': 'Assessed by oral glucose tolerance test.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Calculated from height and weight.'}, {'measure': 'Fasting plasma glucose concentration', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Measured in fasting plasma sample.'}, {'measure': 'Fasting serum insulin concentration', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Measured in fasting serum sample.'}, {'measure': 'Fasting plasma triglyceride concentration', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Measured in fasting plasma sample.'}, {'measure': 'Metabolic endotoxaemia', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Plasma markers of endotoxaemia'}, {'measure': 'Markers of systemic inflammation', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Selected plasma cytokines and chemokines'}, {'measure': 'Incretin response to glucose ingestion', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'GLP-1'}, {'measure': 'Microbiome analysis', 'timeFrame': 'Day 0, Day 21 and Day 28', 'description': 'Faecal DNA analysis of the gut microbiota'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut Microbiota', 'High Fat Diets', 'Probiotics', 'Glycaemic Control'], 'conditions': ['Insulin Sensitivity', 'Insulin Resistance', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Participants will be randomly allocated to either Yakult ingestion or a control group. For the first 20 days, subjects will consume their normal diet (keeping a detailed food diary throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.\n\nThe investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic inflammation as well as decreasing whole body insulin sensitivity (as we have shown previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action / insulin sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females\n* Aged 18-30\n* Physically active (exercising at least 3 times per week for more than 30 min at a time)\n* Non-smoker\n* Free from cardiovascular or metabolic disease\n* Weight stable for at least 6 months\n* Normal body mass index (BMI: 18.5-24.9 kg/m2)\\*\n* Compliant (i.e. understands and is willing, able and likely to comply with all study requirements)\n\n * Note: If BMI is \\>24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion.\n\nExclusion Criteria:\n\n* Using probiotic or prebiotic supplements within the previous 3 months\n* Vegetarians and vegans\n* Diagnosis of insulin resistance, pre-diabetes or full diabetes\n* Underweight (determined as BMI less than 18.5 kg/m2)\n* Overweight or obese (determined as BMI greater than 24.9 kg/m2)\n* Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet.\n* Those who are unwilling to restrict their intake of fermented dairy products.\n* Those with known or suspected food intolerances, allergies or hypersensitivity\n* Women who are known to be pregnant or who are intending to become pregnant over the course of the study.\n* Participation in another clinical trial\n* Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months.\n* Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months.\n* Participants who know they would not be available for all the lab visits during the 4-week study period."}, 'identificationModule': {'nctId': 'NCT03037918', 'briefTitle': 'Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.', 'orgStudyIdInfo': {'id': 'R16-P132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Participants will receive 2 x 65mL doses of Yakult light per day, for 28 days.\n\nParticipants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.', 'interventionNames': ['Dietary Supplement: Yakult light']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.'}], 'interventions': [{'name': 'Yakult light', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A fermented milk drink containing the probiotic Lactobacillus casei Shirota', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE11 3TU', 'city': 'Loughborough', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Loughborough University', 'geoPoint': {'lat': 52.76667, 'lon': -1.2}}], 'overallOfficials': [{'name': 'Carl J Hulston', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loughborough University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loughborough University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yakult Honsha Co., LTD', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Sports Nutrition', 'investigatorFullName': 'Carl Hulston', 'investigatorAffiliation': 'Loughborough University'}}}}