Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07309250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Gastrointestinal Transit Time at the Population Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-10', 'size': 1307506, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-15T04:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 932}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal transit time', 'timeFrame': 'From enrollment to the end of study at 2 weeks', 'description': 'Calculate the transit time by the recorded muffin consuming time, first blue stool appearance time and last blue stool appearance time'}], 'secondaryOutcomes': [{'measure': 'Height (cm)', 'timeFrame': 'baseline', 'description': 'Measured using a height meter, in centimeters.'}, {'measure': 'Weight (kg)', 'timeFrame': 'baseline', 'description': 'Measuring using a scale, in kg.'}, {'measure': 'BMI', 'timeFrame': 'baseline', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Blood glucose (mmol/L)', 'timeFrame': 'baseline', 'description': 'Measure blood glucose by CardioChek Plus in mmol/L'}, {'measure': 'Fat mass (kg)', 'timeFrame': 'baseline', 'description': 'Using Bodystat quadscan 4000 to measure fat mass (kg)'}, {'measure': 'Lean body mass(kg)', 'timeFrame': 'baseline', 'description': 'Using Bodystat quadscan 4000 to measure lean body mass (kg)'}, {'measure': 'Fat percentage (%)', 'timeFrame': 'baseline', 'description': 'Using Bodystat quadscan 4000 to measure fat%'}, {'measure': 'Total cholesterol (mmol/L)', 'timeFrame': 'baseline', 'description': 'Measuring by Mission cholesterol Meter in mmol/L'}, {'measure': 'HDL-C (mmol/L)', 'timeFrame': 'baseline', 'description': 'Measuring by Mission cholesterol Meter in mmol/L'}, {'measure': 'LDL-C (mmol/L)', 'timeFrame': 'baseline', 'description': 'Measuring by Mission cholesterol Meter in mmol/L'}, {'measure': 'Triglyceride (mmol/L)', 'timeFrame': 'baseline', 'description': 'Measuring by Mission Cholesterol Meter in mmol/L'}, {'measure': 'Food record', 'timeFrame': '2 days after study', 'description': 'Participants record their 24-h diets through smartphone application'}, {'measure': 'Stool form', 'timeFrame': 'baseline', 'description': 'Stool form will be evaluated by Bristol Stool Form Scale, the score is from 1 to 7, with values closer to the middle indicating more ideal stool shape.'}, {'measure': 'Hydration status', 'timeFrame': 'baseline', 'description': 'Hydration status will be rated from 1 to 8 by Urine color chart, with higher numbers indicating that the body needs more water.'}, {'measure': 'Perceived level of stress', 'timeFrame': 'baseline', 'description': "The10-item Perceived Stress will be used to measures an individual's perceived level of stress over the past month. The total score ranges from 0 to 40. A higher score indicates a greater perceived level of stress."}, {'measure': 'Sleep quality', 'timeFrame': 'baseline', 'description': 'Pittsburgh Sleep Quality Index will be used to assess subjective sleep quality over the past month. The total score ranges from 0 to 21. A higher score indicates poorer sleep quality.'}, {'measure': 'Activity level', 'timeFrame': 'baseline', 'description': 'The Baecke Physical Activity Questionnaire will be used to assess daily habitual physical activity, with a particular focus on work-related and exercise-related activities. It does not produce a single total score, but rather scores on three dimensions, each typically ranging from 1 to 5. On each dimension, a higher score indicates a higher level of physical activity in that area. Therefore, for assessing activity levels, a higher score is generally better.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal motility', 'Baseline study', 'Reference value'], 'conditions': ['Gastrointestinal Transit Time']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the baseline of gastrointestinal transit time (GITT) and explore its relationship with other health indicators in 932 healthy adult volunteers.\n\nThe main questions it aims to answer are:\n\nWhat are the population-level baseline values for GITT using the blue dye method? How is GITT associated with key physiological parameters including blood metabolic markers, life style, and stool characteristics?\n\nParticipants will:\n\nConsume a standardized blue dye muffin after overnight fasting at the research center; Offer a finger prock blood samples for metabolic profiling; Collect stool samples for moisture measurement; Complete detailed questionnaires on diet, lifestyle, and bowel habits; Record the time of first blue stool appearance to determine GITT.', 'detailedDescription': 'This explorative study is designed as a cross-sectional investigation aimed at establishing population-level reference values for gastrointestinal transit time (GITT). Adult participants from the general population will undergo GITT measurement using the blue-dye method. This muffin contains blue colorant that cannot be absorbed; after ingestion, it passes through the entire gastrointestinal tract and is eventually excreted in feces. Following a two-day lifestyle standardization period (including dietary and activity guidance) to minimize potential confounding effects on gastrointestinal motility, participants will attend a clinical visit where they will ingest a blue muffin. GITT will be determined by measuring both the time interval between ingestion of the blue muffin and the first appearance of blue-colored stool, and the duration from its first appearance to its complete disappearance.\n\nThe blue muffin method has been well-established in previous research for GITT assessment. Building upon the methodology developed by Berry et al., we will introduce stricter pre-test condition controls (includes dietary advice and lifestyle recommendations) and optimized the blue muffin formulation.These improvements allow for reliable measurement with a single muffin administration, which has been evaluated through KU Leuven Health Pass in a large sample size(S-70168).\n\nTo investigate potential determinants and correlates of GITT, we will collect biochemical parameters, fecal moisture, and resting metabolic rate. Additionally, participants will complete 24-h diet record and health questionnaires assessing bowel movement, physical activity habits, stress levels, sleep quality and hydration condition for subsequent correlation analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers from the Flanders region who volunteered to participate in the research', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18-65 years old\n2. 18.5 kg/m² ≤ BMI ≤ 25 kg/m² or BMI ≥ 30 kg/m² (people with normal weight or obesity)\n3. Provision of informed consent to participate.\n\nExclusion Criteria:\n\n1. Gastrointestinal conditions which may affect nutrient absorption or gastric emptying, including coeliac disease, Crohn's disease, previous resection of the small intestine other than bariatric surgery, gastroparesis;\n2. Using medications which effect gastric motility (e.g., domperidone, erythromycin, metoclopramide, prucalopride, opiates, loperamide, …)\n3. The ingredients of blue muffins include gluten, nuts, baking powder, sugar, vanilla extract and sunflower oil. Participants with allergies to these ingredients;\n4. Current diagnosis of cancer;\n5. Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Child-Pugh B or C, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4;\n6. Immobility;\n7. Neuromuscular degenerative conditions associated with muscular atrophy, such as myasthenia gravis, muscular dystrophies, fibromyalgia, or multiple Sclerosis;"}, 'identificationModule': {'nctId': 'NCT07309250', 'acronym': 'GITTPop', 'briefTitle': 'A Study on Gastrointestinal Transit Time at the Population Level', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Gastrointestinal Transit Time at the Population Level: A Cross-sectional Study', 'orgStudyIdInfo': {'id': 'S70908'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult participants', 'description': 'Healthy adult participants without serious gastrointestinal diseases', 'interventionNames': ['Other: Diet']}], 'interventions': [{'name': 'Diet', 'type': 'OTHER', 'description': 'Participants will consume a regular muffin containing blue dye', 'armGroupLabels': ['Adult participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Flemish Brabant', 'country': 'Belgium', 'contacts': [{'name': 'Wim Janssens', 'role': 'CONTACT', 'email': 'wim.janssens@kuleuven.be', 'phone': '+32 016252111'}, {'name': 'Evelyne van Etten', 'role': 'CONTACT', 'email': 'evelyne.vanetten@kuleuven.be', 'phone': '+32 016330855'}], 'facility': 'Department of Chronic Diseases and Metabolism', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Christophe Matthys', 'role': 'CONTACT', 'email': 'christophe.matthys@uzleuven.be', 'phone': '+32 016342655'}, {'name': 'Wei Li', 'role': 'CONTACT', 'email': 'wei.li2@kuleuven.be', 'phone': '+32 016344539'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christophe Matthys', 'investigatorAffiliation': 'KU Leuven'}}}}