Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT05378295
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2022-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Fiber and Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral insulin sensitivity', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change of peripheral insulin sensitivity (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp'}], 'secondaryOutcomes': [{'measure': 'Energy expenditure (indirect calorimetry)', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in energy expenditure as measured via ventilated hood system'}, {'measure': 'Substrate oxidation (indirect calorimetry)', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in substrate oxidation as measured via ventilated hood system'}, {'measure': 'circulating SCFA', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in concentrations of circulating SCFA'}, {'measure': 'Faecal SCFA', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in concentrations of faecal SCFA'}, {'measure': 'Faecal microbiota composition and in vitro microbial activity testing', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene'}, {'measure': 'Circulating hormones such as insulin', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in concentrations of circulating hormones in peripheral blood'}, {'measure': 'Circulating metabolites such as glucose', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in concentrations of metabolites in peripheral blood'}, {'measure': 'body fat percentage', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in body fat percentage as assessed using DEXA scans'}, {'measure': 'fat mass', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in fat mass in kg as assessed using DEXA scans'}, {'measure': 'lean mass', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in lean mass in kg as assessed using DEXA scans'}, {'measure': 'visceral fat', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in visceral fat in gram as assessed using DEXA scans'}, {'measure': 'body weight', 'timeFrame': 'Before and 12 week after the start of the intervention', 'description': 'The change in body weight in kg using a weight scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': "In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:\n\n1. To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals;\n2. To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOverweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 \\< 40 kg/m2)\n\nExclusion Criteria:\n\n* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)\n* Gastroenterological diseases or abdominal surgery;\n* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;\n* Abuse of products; alcohol and drugs, excessive nicotine use defined as \\>20 cigarettes per day;\n* Plans to lose weight or following of a hypocaloric diet;\n* Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;\n* Intensive exercise training more than three hours a week;\n* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);\n* Regular use of laxation products;\n* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).\n* Follow a vegetarian diet.'}, 'identificationModule': {'nctId': 'NCT05378295', 'briefTitle': 'Personalized Fiber and Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Personalized Microbial Substrates to Prevent Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NL76905.068.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'isocaloric fermentable oligosaccaride', 'description': 'isocaloric fermentable oligosaccaride', 'interventionNames': ['Dietary Supplement: Fermentable oligosaccharide']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized fiber mixture', 'description': '12 g for 2 weeks, followed by 24 g for 10 weeks', 'interventionNames': ['Dietary Supplement: Personalized fiber mixture']}], 'interventions': [{'name': 'Fermentable oligosaccharide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation period 12 weeks', 'armGroupLabels': ['isocaloric fermentable oligosaccaride']}, {'name': 'Personalized fiber mixture', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation period 12 weeks', 'armGroupLabels': ['Personalized fiber mixture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5229ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}