Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-31 @ 12:37 AM
Study NCT ID:
NCT01073969
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-22', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight)', 'timeFrame': 'Baseline to end of each treatment (week 0 to week 3 of each treatment)'}], 'secondaryOutcomes': [{'measure': 'Other fecal bacterial counts', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'laxation', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'fecal pH', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'fecal moisture', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'stool consistency', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'blood glucose', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'Blood insulin', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'plasma lipid profiles', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'serum free fatty acids', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'fecal short chain fatty acids', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'fecal ammonia', 'timeFrame': 'baseline to end of each treament (week 0 to week 3 of each treatment)'}, {'measure': 'urinary para-cresol', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'urinary phenol (total)', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'urinary isoprostanes', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'oxidized low density lipoprotein (TBARS, conjugated dienes)', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'Urinary F2alpha-isoprostanes', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'Plasma antioxidant capacity (ORAC, FRAP)', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'serum amyloid A', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'hs-CRP', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'IL-6', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'TNF-alpha', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'gastrointestinal symptom survey', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'stool consistency (Bristol stool scale)', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}, {'measure': 'Quality of Life questionaire (Quality Metrics SF-36)', 'timeFrame': 'baseline to end of each treatment (week 0 to week 3 of each treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prebiotic study', 'modulating colonic bacteria'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* 18-75 years of age\n* Body mass index ≥18.5 and \\<35.0 kg/m2\n* Fasting LDL-C level ≥100 mg/dL and \\<200 mg/dL\n* Otherwise judged to be in good health, willing to maintain habitual food and beverage intake and physical activity patterns throughout the trial\n\nExclusion Criteria:\n\n* Significant gastrointestinal condition\n* Use of pre/probiotic foods or supplements\n* Use of antibiotics\n* Pregnancy\n* Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications\n* Poorly controlled hypertension\n* Cancer treated within prior 2 years'}, 'identificationModule': {'nctId': 'NCT01073969', 'briefTitle': 'Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kellogg Company'}, 'officialTitle': 'A Double-blind, Randomized, Controlled Crossover Trial to Assess the Digestive and Physiological Effects of a Wheat Bran Extract in Healthy Men and Women', 'orgStudyIdInfo': {'id': 'PRV-08011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control cereal', 'description': 'grain-based ready to eat cereal that does not contain active wheat bran extract', 'interventionNames': ['Other: control wheat bran extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low dose', 'description': 'grain-based ready to eat cereal containing a low dose of wheat bran extract', 'interventionNames': ['Other: wheat bran extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose', 'description': 'grain-based ready to eat cereal that contains a high dose of wheat bran extract', 'interventionNames': ['Other: wheat bran extract']}], 'interventions': [{'name': 'wheat bran extract', 'type': 'OTHER', 'otherNames': ['wheat bran oligosccharides', 'prebiotic oligosccharides'], 'description': 'Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract', 'armGroupLabels': ['High dose', 'low dose']}, {'name': 'control wheat bran extract', 'type': 'OTHER', 'otherNames': ['wheat bran oligosccharides', 'prebiotic oligosccharides'], 'description': 'Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract', 'armGroupLabels': ['Control cereal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60137', 'city': 'Glen Ellyn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Provident CRC', 'geoPoint': {'lat': 41.87753, 'lon': -88.06701}}], 'overallOfficials': [{'name': 'Kevin Maki, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Provident Clinical Research and Consulting, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kellogg Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Provident Clinical Research', 'class': 'OTHER'}, {'name': 'Tufts University', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'University of Reading', 'class': 'OTHER'}, {'name': 'University of Saskatchewan', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Robin Dickmann, Senior Nutrition Scientist', 'oldOrganization': 'Kellogg Company'}}}}