Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-02 @ 3:41 PM
Study NCT ID:
NCT02500069
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Location Specific Differences in Intestinal Brake Activation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002364', 'term': 'Caseins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010750', 'term': 'Phosphoproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure ad libitum food intake at the end of the test day', 'timeFrame': '1 test day', 'description': 'Food intake measurement in kcal'}], 'secondaryOutcomes': [{'measure': 'VAS scores for hunger and satiety', 'timeFrame': '1 test day', 'description': 'Visual analogue scale for hunger and satiety in mm (0-100 mm scale)'}, {'measure': 'GI peptides', 'timeFrame': '1 test day', 'description': 'Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ileal Brake', 'Satiety', 'Overweight', 'Obesity', 'Overeating']}, 'referencesModule': {'references': [{'pmid': '27811949', 'type': 'DERIVED', 'citation': 'van Avesaat M, Ripken D, Hendriks HF, Masclee AA, Troost FJ. Small intestinal protein infusion in humans: evidence for a location-specific gradient in intestinal feedback on food intake and GI peptide release. Int J Obes (Lond). 2017 Feb;41(2):217-224. doi: 10.1038/ijo.2016.196. Epub 2016 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Based on medical history and previous examination, no gastrointestinal complaints can be defined.\n* Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.\n* BMI between 18 and 25 kg/m2)\n* Weight stable over at least the last 6 months (≤5% weight change)\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.\n* Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing\n* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study\n* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)\n* Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)\n* Pregnancy, lactation\n* Excessive alcohol consumption (\\>20 alcoholic consumptions per week)\n* Smoking\n* Blood donation within 3 months before the study period\n* Self-admitted HIV-positive state\n* Weight \\<60kg\n* Evidence of casein or sucrose hypersensitivity\n* Participation in any other study in which radiation was used, within 12 months before the study period'}, 'identificationModule': {'nctId': 'NCT02500069', 'briefTitle': 'Location Specific Differences in Intestinal Brake Activation', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release', 'orgStudyIdInfo': {'id': 'METC-14-3-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tap water infusion in all three locations (duodenum, jejunum and ileum)', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Duodenum', 'description': 'Infusion of casein in duodenum', 'interventionNames': ['Other: Casein (in duodenum)']}, {'type': 'EXPERIMENTAL', 'label': 'Jejunum', 'description': 'Infusion of casein in jejunum', 'interventionNames': ['Other: Casein (in jejunum)']}, {'type': 'EXPERIMENTAL', 'label': 'Ileum', 'description': 'Infusion of casein in ileum', 'interventionNames': ['Other: Casein (in ileum)']}], 'interventions': [{'name': 'placebo', 'type': 'OTHER', 'description': 'infusion of tap water in all regions (duodenum, jejunum and ileum)', 'armGroupLabels': ['Placebo']}, {'name': 'Casein (in duodenum)', 'type': 'OTHER', 'description': 'infusion of protein in duodenum', 'armGroupLabels': ['Duodenum']}, {'name': 'Casein (in jejunum)', 'type': 'OTHER', 'description': 'infusion of protein in jejunum', 'armGroupLabels': ['Jejunum']}, {'name': 'Casein (in ileum)', 'type': 'OTHER', 'description': 'infusion of protein in ileum', 'armGroupLabels': ['Ileum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6003', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'A Masclee, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}