Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-13 @ 11:55 PM
Study NCT ID:
NCT04740112
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta-glucan, Product Claims and Satiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'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': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hunger', 'timeFrame': '30 minutes after consumption', 'description': 'Hunger as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Hunger', 'timeFrame': '60 minutes after consumption', 'description': 'Hunger as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Hunger', 'timeFrame': '90 minutes after consumption', 'description': 'Hunger as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Hunger', 'timeFrame': '120 minutes after consumption', 'description': 'Hunger as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Hunger', 'timeFrame': '180 minutes after consumption', 'description': 'Hunger as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Fullness', 'timeFrame': '30 minutes after consumption', 'description': 'Fullness as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Fullness', 'timeFrame': '60 minutes after consumption', 'description': 'Fullness as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Fullness', 'timeFrame': '90 minutes after consumption', 'description': 'Fullness as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Fullness', 'timeFrame': '120 minutes after consumption', 'description': 'Fullness as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Fullness', 'timeFrame': '180 minutes after consumption', 'description': 'Fullness as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Desire to eat', 'timeFrame': '30 minutes after test meal consumption', 'description': 'Desire to eat as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Desire to eat', 'timeFrame': '60 minutes after test meal consumption', 'description': 'Desire to eat as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Desire to eat', 'timeFrame': '90 minutes after test meal consumption', 'description': 'Desire to eat as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Desire to eat', 'timeFrame': '120 minutes after test meal consumption', 'description': 'Desire to eat as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Desire to eat', 'timeFrame': '180 minutes after test meal consumption', 'description': 'Desire to eat as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Prospective consumption', 'timeFrame': '30 minutes after test meal consumption', 'description': 'Prospective consumption as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Prospective consumption', 'timeFrame': '60 minutes after test meal consumption', 'description': 'Prospective consumption as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Prospective consumption', 'timeFrame': '90 minutes after test meal consumption', 'description': 'Prospective consumption as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Prospective consumption', 'timeFrame': '120 minutes after test meal consumption', 'description': 'Prospective consumption as measured by visual analog scales in mm using appetite questionnaires'}, {'measure': 'Prospective consumption', 'timeFrame': '180 minutes after test meal consumption', 'description': 'Prospective consumption as measured by visual analog scales in mm using appetite questionnaires'}], 'secondaryOutcomes': [{'measure': 'Flavor rating', 'timeFrame': '30 minutes after test meal consumption', 'description': 'Subjective ratings on liking of the product flavor using Likert scales'}, {'measure': 'Sweetness rating', 'timeFrame': '30 minutes after test meal consumption', 'description': 'Subjective ratings on sweetness of the product using Likert scales'}, {'measure': 'Texture rating', 'timeFrame': '30 minutes after test meal consumption', 'description': 'Subjective ratings on liking of the product texture using Likert scales'}, {'measure': 'Overall product liking', 'timeFrame': '30 minutes after test meal consumption', 'description': 'Subjective ratings on overall liking of the product using Likert scales'}, {'measure': 'Purchase intent', 'timeFrame': '180 minutes after test meal consumption', 'description': 'Likelihood of buying the product using Likert scales'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a digital clinical trial to investigate satiety and consumer preference in responses to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product packages (with or without product claims) in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 18-70 years.\n* Habitual snack bar consumers (consume bars at least 3 times a week).\n* Body mass index 20-29.9 kg/m² (based on self-reported weight and height).\n* Understand the study procedures.\n* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.\n* Willing to follow study procedures on test days.\n* Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day.\n* Willing to provide informed consent to participate in the study.\n* Willing to maintain confidentiality of the study and test products.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or women who are planning to become pregnant during the study\n* Known food allergies, sensitivity, or intolerance to any food or food ingredients\n* Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification\n* Taking medications that affect appetite, metabolism, or blood pressure\n* Taking supplements with dietary fiber\n* Presence of acute diseases or infection\n* Presence or history of chronic diseases\n* Diagnosed with eating disorders\n* Restraint eaters\n* Lost or gained 5 pounds or more in the past 3 months'}, 'identificationModule': {'nctId': 'NCT04740112', 'briefTitle': 'Beta-glucan, Product Claims and Satiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'General Mills'}, 'officialTitle': 'Effects of Beta-glucan and Product Claims for Breakfast Bars on Appetite Response and Consumer Preference: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021/01/7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control breakfast bar with low dietary fiber without product claims', 'interventionNames': ['Other: Foods with beta-glucan from oats and barley']}, {'type': 'EXPERIMENTAL', 'label': 'Test breakfast bar with high dietary fiber without product claims', 'interventionNames': ['Other: Foods with beta-glucan from oats and barley']}, {'type': 'EXPERIMENTAL', 'label': 'Test breakfast bar with high dietary fiber with product claims', 'interventionNames': ['Other: Foods with beta-glucan from oats and barley']}], 'interventions': [{'name': 'Foods with beta-glucan from oats and barley', 'type': 'OTHER', 'otherNames': ['Food'], 'description': 'Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image', 'armGroupLabels': ['Control breakfast bar with low dietary fiber without product claims', 'Test breakfast bar with high dietary fiber with product claims', 'Test breakfast bar with high dietary fiber without product claims']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55427', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'No physical visit to a research facility is required.', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Mills', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}