Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT00889993
Status:
COMPLETED
Last Update Posted:
2012-03-29
First Post:
2009-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satiety Response After Mixed Fiber Doses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satiety and Food Intake', 'timeFrame': 'November 2007 thru May 2008'}], 'secondaryOutcomes': [{'measure': 'Glucose, Insulin, Gut Hormone Response', 'timeFrame': 'November 2007 thru October 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food intake', 'Gut hormones', 'Fiber', 'Visual analog scales'], 'conditions': ['Satiety']}, 'referencesModule': {'references': [{'pmid': '21310305', 'type': 'DERIVED', 'citation': 'Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.'}]}, 'descriptionModule': {'briefSummary': 'People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.\n\nThe investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* healthy men and women\n* 18 and 65 years of age\n* non-smoking\n* not taking medications\n* non-dieting (weight stable over last 3 months)\n* BMI between 18 and 27\n* able to give blood through an IV\n\nExclusion Criteria:\n\n* irregular or erratic breakfast eating patterns\n* food allergies to ingredients commonly found in muffins or pizza\n* distaste for muffins or pizza\n* BMI less than 18 or greater than 27\n* weight change \\> 5 kg in last 3 months (intentional or unintentional)\n* cardiovascular disease\n* diabetes mellitus (fasting blood sugar \\> 126 mg/dl)\n* cancer in prior 5 years (except basal cell carcinoma of skin)\n* renal or hepatic disease\n* Crohns disease\n* ulcerative colitis\n* any other gastrointestinal conditions that may affect digestion or absorption\n* recent bacterial infection (\\< 3 months)\n* chronic medication use\n* history of drug or alcohol abuse in prior 6 months\n* concurrent or recent intervention study participation\n* vegetarians\n* people who ate more than approximately 15 g of fiber per day\n* pregnant or lactating women\n* women with irregular menstrual cycles'}, 'identificationModule': {'nctId': 'NCT00889993', 'briefTitle': 'Satiety Response After Mixed Fiber Doses', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release', 'orgStudyIdInfo': {'id': '0701M00265'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mixed Fiber Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota: General Clinical Research Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Joanne L Slavin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}