Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01002651
Status:
COMPLETED
Last Update Posted:
2009-10-27
First Post:
2009-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-26', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bifidobacteria content in feces', 'timeFrame': 'day 19 or 20 of each intervention'}, {'measure': 'butyric acid content in feces', 'timeFrame': 'day 19 or 20 of each intervention'}, {'measure': 'p-cresol content in urine', 'timeFrame': 'day 19-21 of each intervention'}, {'measure': 'stool frequency', 'timeFrame': 'third week of each intervention'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'whole study'}, {'measure': 'clinical blood parameters', 'timeFrame': 'day 21 of each intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastrointestinal health', 'healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).\n\nThe objective of this study is to analyze the effect of the intake of two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18-90 years of age, inclusive\n* Regular eating habits\n* Body Mass Index (BMI) between 18.5 and 30 kg/m2\n* Consent to take in the study product according to the study protocol\n* Subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)\n* For female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception\n\nExclusion Criteria:\n\n* Low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial\n* Recent use of antibiotics\n* Abdominal surgery in the past\n* Serious illness within 3 months of start of clinical trial\n* Use of medication or dietary supplements known to influence GI tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication\n* Complete anesthetics within 1 month of the start of the clinical trial\n* Chronic GI conditions such as inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance\n* Allergy for wheat products\n* Celiac disease\n* For female volunteers: pregnant or lactating\n* Alcohol abuse\n* Smoking more than 5 cigarettes per day\n* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.'}, 'identificationModule': {'nctId': 'NCT01002651', 'briefTitle': 'In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fugeia NV'}, 'officialTitle': 'In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study', 'orgStudyIdInfo': {'id': 'ML5282'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wheat Bran Extract (high dose)', 'interventionNames': ['Dietary Supplement: wheat bran extract']}, {'type': 'EXPERIMENTAL', 'label': 'Wheat Bran Extract (low dose)', 'interventionNames': ['Dietary Supplement: wheat bran extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'wheat bran extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['arabinoxylan-oligosaccharides (AXOS)'], 'description': 'soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner', 'armGroupLabels': ['Wheat Bran Extract (high dose)', 'Wheat Bran Extract (low dose)']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Department of Gastrointestinal Research, Laboratory Digestion and Absorption', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Willem Broekaert, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fugeia NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fugeia NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kristin Verbeke, Ph.D.', 'oldOrganization': 'Katholieke Universiteit Leuven'}}}}