Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT06645756
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2023-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Microbiome RNA in serum', 'timeFrame': 'baseline'}, {'measure': 'IgA in serum', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Fecal microbiome analysis', 'timeFrame': 'baseline'}], 'primaryOutcomes': [{'measure': 'LPS', 'timeFrame': '30 min after test meal', 'description': 'LPS in Serum'}, {'measure': 'LPS', 'timeFrame': '60 min after test meal', 'description': 'LPS in Serum'}, {'measure': 'LPS', 'timeFrame': '120 min after test meal', 'description': 'LPS in Serum'}, {'measure': 'LPS', 'timeFrame': '180 min after test meal', 'description': 'LPS in Serum'}, {'measure': 'LPS', 'timeFrame': '240 min after test meal', 'description': 'LPS in Serum'}], 'secondaryOutcomes': [{'measure': 'Activability of PBMCs in vitro', 'timeFrame': 'immediately after the intervention', 'description': 'To analyze the reactivity of PBMCs, these are isolated, co-cultivated with bacteria and then the number of replicable bacteria is counted.'}, {'measure': 'Serum cytokines and PAMPs', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Characterization of PBMCs', 'timeFrame': 'immediately after the intervention', 'description': 'The PBMCs are characterized by fluorescence-activated cell sorting (FACS) and RNA isolation.'}, {'measure': 'Metabolome analyses', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Trimethylamine / SCFA in serum', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'immediately after the intervention'}, {'measure': 'lipoproteins', 'timeFrame': 'immediately after the intervention'}, {'measure': 'HbA1c', 'timeFrame': 'immediately after the intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-fat diet', 'high-calorie diet', 'leukocytes', 'LPS'], 'conditions': ['Obesity', 'Normal Weigth']}, 'descriptionModule': {'briefSummary': 'After eating, blood composition changes, including increased triglycerides and glucose, which can trigger postprandial inflammation. Particularly with high-fat foods, pro-inflammatory lipopolysaccharide (LPS) increases. This activates leukocytes to release pro-inflammatory cytokines. In industrialized countries where "snacking" is common, many people spend the day in a postprandial state. Obese individuals tend to have chronic inflammation and show increased susceptibility to infections such as SARS-CoV-2. The main objective of the study is to investigate the response of leukocytes and the serum metabolome after food intake in individuals with obesity compared to healthy individuals, focusing on LPS as a key stimulus of innate immunity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed declaration of consent\n* from 25 years of age\n* BMI 20 kg/m2 - 25 kg/m2 or BMI 30 kg/m2 - 40 kg/m2\n* Good venous conditions for blood collection\n* Sufficient understanding of the German language and sufficient mental state to understand information and instructions related to the study\n\nExclusion Criteria:\n\n* Nicotine consumption\n* High-risk alcohol consumption (more than one standard glass per day for women, more than two standard glasses per day for men)\n* Antibiotic intake\n* Taking probiotics, prebiotics and synbiotics, unless taken for more than 90 days\n* Taking statins or other lipid-lowering medications (e.g., ezetimibe, fibrates)\n* Taking oral antidiabetics\n* Taking antacids\n* Manifest diabetes mellitus\n* Acute/unstable cardiovascular diseases\n* Acute inflammatory diseases\n* autoimmune diseases\n* kidney diseases\n* food allergy or food intolerance to food components of the test meal (e.g. eggs)\n* celiac disease\n* Pregnancy and lactation\n* Inability to consume the test meal orally\n* Placement in a clinic or similar facility due to official or court order (medical history)\n* Participation in another clinical study (current or within the last 30 days prior to study entry)\n* A medical condition or regular medication use that, at the investigator's discretion, does not permit study participation or evaluation of study parameters or consumption of the investigational product (individual decision)"}, 'identificationModule': {'nctId': 'NCT06645756', 'acronym': 'CAPE', 'briefTitle': 'Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals', 'orgStudyIdInfo': {'id': 'UniHohMet-CAPE-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese group', 'description': 'Test meal', 'interventionNames': ['Other: Test meal']}, {'type': 'EXPERIMENTAL', 'label': 'Normal weight group', 'description': 'Test meal', 'interventionNames': ['Other: Test meal']}], 'interventions': [{'name': 'Test meal', 'type': 'OTHER', 'description': 'Test meal consisting of fries, chicken nuggets and eggs', 'armGroupLabels': ['Normal weight group', 'Obese group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70599', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Metabolic Unit der Universität Hohenheim', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Stephan C. Bischoff, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hohenheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Case-by-case decision after contact'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}