Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-27 @ 3:26 AM
Study NCT ID:
NCT04596969
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001070', 'term': 'Appetitive Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Material was provided in coded plain packaging. Participants and researchers were unaware of what was being received.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Human subjects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': '10 hours', 'description': 'Food intake measured at lunch and evening meal.'}], 'secondaryOutcomes': [{'measure': 'Appetite', 'timeFrame': '10 hours', 'description': 'Subjective appetite measures using questionnaires at regular intervals over 10 hours,'}, {'measure': 'CCK', 'timeFrame': '10 hours', 'description': 'Plasma CCK measured at regular intervals over 10 hours.'}, {'measure': 'GLP-1', 'timeFrame': '10 hours', 'description': 'Plasma GLP-1 measured at regular intervals over 10 hours.'}, {'measure': 'PYY3-36', 'timeFrame': '10 hours', 'description': 'Plasma PYY3-36 measured at regular intervals over 10 hours.'}, {'measure': 'Breath Hydrogen', 'timeFrame': '10 hours', 'description': 'Breath hydrogen measured at regular intervals over 10 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appetitive Behavior']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this study. Participants were given two doses of SFD in the morning and appetite, food intake and physiological markers of appetite were measured over 10 years.', 'detailedDescription': 'Overweight and obesity are leading health problems. The study investigates the effect of a food ingredient from two different sources at two different doses on food intake and appetite markers over a 10 hour period. All participants reported to the laboratory first thing in the morning and remained in the laboratory until after their evening meal. A fixed breakfast was served but the participants were free to eat as much as they liked at lunch and dinner. Blood was taken at regular intervals during the day and assayed for glucose and several hormones related to appetite. Subjective measures of appetite were also collected over the 10 hour test session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI 19.9 - 29.9 Aged 18-45 Find the study foods to be palatable\n\nExclusion Criteria:\n\nWeight change \\> 3kg in the past three months Do not regularly consume snacks Presence or history of GI disorders Restrained eater Used medication that influences appetite'}, 'identificationModule': {'nctId': 'NCT04596969', 'briefTitle': 'The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite', 'organization': {'class': 'OTHER', 'fullName': 'Iowa State University'}, 'officialTitle': 'The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite: a Randomized Trial', 'orgStudyIdInfo': {'id': 'SFDISU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SFD Tapioca 20g', 'description': '20g soluble fiber dextrin derived from tapioca', 'interventionNames': ['Other: Soluble Fiber Dextrin']}, {'type': 'EXPERIMENTAL', 'label': 'SFD Tapioca 40g', 'description': '40g soluble fiber dextrin derived from tapioca', 'interventionNames': ['Other: Soluble Fiber Dextrin']}, {'type': 'EXPERIMENTAL', 'label': 'SFD corn 20g', 'description': '40g soluble fiber dextrin derived from corn', 'interventionNames': ['Other: Soluble Fiber Dextrin']}, {'type': 'EXPERIMENTAL', 'label': 'SFD corn 40g', 'interventionNames': ['Other: Soluble Fiber Dextrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Maltodextrin', 'interventionNames': ['Other: Soluble Fiber Dextrin']}], 'interventions': [{'name': 'Soluble Fiber Dextrin', 'type': 'OTHER', 'description': 'Ingredient based on resistant starch', 'armGroupLabels': ['Control', 'SFD Tapioca 20g', 'SFD Tapioca 40g', 'SFD corn 20g', 'SFD corn 40g']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iowa State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}