Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT05120661
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2021-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postprandial glucose response (iAUC) per test product', 'timeFrame': '0-120 minutes', 'description': 'iAUC glucose'}, {'measure': 'small intestine microbiome', 'timeFrame': 'at baseline', 'description': 'the relative composition (%) and the functional capacity (%) of the small intestine microbiota'}], 'secondaryOutcomes': [{'measure': 'macronutrients in the small intestinal aspirates', 'timeFrame': '0-240 minutes', 'description': 'amounts of carbohydrates, proteins, fats'}, {'measure': 'presence and production of (bacterial) degradation products in the small intestinal aspirates', 'timeFrame': '0-240 minutes', 'description': 'concentrations of organic acids and short-chain fatty acids'}, {'measure': 'digestive enzymes in the small intestinal aspirates', 'timeFrame': '0-240 minutes', 'description': 'concentrations of amylase'}, {'measure': 'non-absorbable marker in the small intestinal aspirates', 'timeFrame': '0-240 minutes', 'description': 'peg-4000 concentrations'}, {'measure': 'blood HbA1c', 'timeFrame': '0-240 minutes', 'description': 'concentrations of HbA1c'}, {'measure': 'blood glucose', 'timeFrame': '0-240 minutes', 'description': 'concentrations glucose (e.g. GLP-1, PYY)'}, {'measure': 'blood insulin', 'timeFrame': '0-240 minutes', 'description': 'concentrations of insulin'}, {'measure': 'blood glucagon', 'timeFrame': '0-240 minutes', 'description': 'concentrations of glucagon'}, {'measure': 'blood total triglycerides', 'timeFrame': '0-240 minutes', 'description': 'concentrations of triglycerides'}, {'measure': 'blood total free fatty acids', 'timeFrame': '0-240 minutes', 'description': 'concentrations of free fatty acids'}, {'measure': 'plasma gut hormones', 'timeFrame': '0-240 minutes', 'description': 'concentrations of gut hormones (e.g. GLP-1, PYY)'}, {'measure': 'breath 13C-lactosyl ureide', 'timeFrame': '0-240 minutes', 'description': 'concentrations of 13C-lactosyl ureide'}, {'measure': 'breath hydrogen', 'timeFrame': '0-240 minutes', 'description': 'concentrations of hydrogen (ppm)'}, {'measure': 'breath methane', 'timeFrame': '0-240 minutes', 'description': 'concentrations of methane (ppm)'}, {'measure': 'Oral microbiome composition', 'timeFrame': 'baseline', 'description': 'microbiota relative composition (%)'}, {'measure': 'Salivary α-amylase', 'timeFrame': '0-240 minutes', 'description': 'concentrations of a-amylase'}, {'measure': 'Fecal microbiota composition', 'timeFrame': 'baseline', 'description': 'microbiota relative composition (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Obesity', 'Overweight', 'Microbiota', 'Small Intestine', 'Digestion']}, 'descriptionModule': {'briefSummary': 'It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.', 'detailedDescription': 'Rationale: It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Differences in small intestine microbiota are hypothesized to be key in explaining the interpersonal differences in glycemic responses.\n\nObjective: To investigate the role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products.\n\nStudy design: The subjects will wear a continuous glucose monitor during the screening and the study. First a screening (14 days in total) will take place with to choose the test products (2 out of 4) that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. Also an OGTT will be performed. The study will be a randomized cross-over trial with two test days (length of trial is 6 days in total). During the trial, the subjects will be intubated with a naso-jejunum catheter.\n\nStudy population: Twenty men or women (BMI≥25 kg/m2, 40-75 years old). Intervention (if applicable): Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test.\n\nMain study parameters/endpoints: test (food) product-induced plasma glucose responses (iAUC), small intestine microbiota.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females\n* BMI≥25 kg/m2\n* Age 40-75 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants;\n* Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;\n* Use of antibiotics within 2 months of starting the study or planned during the study;\n* Use of medication that could influence the study results, such as diabetes treatment;\n* Use of pro- and prebiotic supplements;\n* Sensitive to medical skin adhesives;\n* Having an allergy or intolerance towards compounds in the test products;\n* Follows a vegan diet;\n* Excessive alcohol consumption (on average \\>21 glasses/week for men and \\>14 glasses/week for women);\n* Currently a research subject in another clinical trial;\n* Having blood vessels that are too difficult for inserting a cannula/blood drawing'\n* Having a hemoglobin level \\<8.5 mmol/l (men) or \\<7.5 mmol/l (women);\n* Being a blood donor during the duration of the study;\n* Not having a General Practitioner (GP);\n* Being an employee of Wageningen University, division Human Nutrition and Health."}, 'identificationModule': {'nctId': 'NCT05120661', 'acronym': 'GLYSIMI', 'briefTitle': 'Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Elucidating the Role of Human Small Intestine Microbiota in Interpersonal Differences in GLYcemic Responses Upon Consumption of Food Products: A Proof of Principle Study', 'orgStudyIdInfo': {'id': 'NL78737.091.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbohydrate-rich food product (to be determined)', 'description': 'This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates.', 'interventionNames': ['Other: food product']}, {'type': 'EXPERIMENTAL', 'label': 'Another carbohydrate-rich food product (to be determined)', 'description': 'This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates.', 'interventionNames': ['Other: food product']}], 'interventions': [{'name': 'food product', 'type': 'OTHER', 'description': 'a food product containing 50 gram carbohydrates', 'armGroupLabels': ['Another carbohydrate-rich food product (to be determined)', 'Carbohydrate-rich food product (to be determined)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guido Hooiveld', 'investigatorAffiliation': 'Wageningen University'}}}}