Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00888602
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2009-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effects of Psyllium on Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011620', 'term': 'Psyllium'}, {'id': 'D062407', 'term': 'Meals'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2009-04-24', 'studyFirstSubmitQcDate': '2009-04-24', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Men']}, 'descriptionModule': {'briefSummary': 'This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* 18 to 50 years of age\n* general good health\n* Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2\n* fasting plasma blood glucose \\<126mg/dL\n* not actively treated for high blood glucose\n* willing and able to have blood drawn at multiple times during each 4 visits\n\nExclusion Criteria:\n\n* history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients\n* Phenylketonuria (PKU)\n* an eating disorder\n* following special medical or weight-loss dietary restrictions\n* taking dietary supplements or prescription medication for the purpose of weight loss/management'}, 'identificationModule': {'nctId': 'NCT00888602', 'briefTitle': 'Study to Evaluate the Effects of Psyllium on Blood Glucose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males', 'orgStudyIdInfo': {'id': '2009001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MM1 - Meal', 'description': '3.4g psyllium served with a meal', 'interventionNames': ['Dietary Supplement: 3.4 g psyllium']}, {'type': 'EXPERIMENTAL', 'label': 'MM2 - Meal', 'description': '6.8 g psyllium served with a meal', 'interventionNames': ['Dietary Supplement: 6.8 g psyllium']}, {'type': 'EXPERIMENTAL', 'label': 'MM2 (no Meal)', 'description': '6.8 g psyllium consumed with no meal', 'interventionNames': ['Dietary Supplement: 6.8 g psyllium']}, {'type': 'SHAM_COMPARATOR', 'label': 'Meal Only', 'description': 'meal only', 'interventionNames': ['Other: Meal']}], 'interventions': [{'name': '3.4 g psyllium', 'type': 'DIETARY_SUPPLEMENT', 'description': '3.4 g psyllium served with meal', 'armGroupLabels': ['MM1 - Meal']}, {'name': '6.8 g psyllium', 'type': 'DIETARY_SUPPLEMENT', 'description': '6.8 g psyllium served with a meal', 'armGroupLabels': ['MM2 - Meal']}, {'name': '6.8 g psyllium', 'type': 'DIETARY_SUPPLEMENT', 'description': '6.8 g psyllium', 'armGroupLabels': ['MM2 (no Meal)']}, {'name': 'Meal', 'type': 'OTHER', 'description': 'meal', 'armGroupLabels': ['Meal Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Miamiville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hill Top Research', 'geoPoint': {'lat': 39.21256, 'lon': -84.29938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}