Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT06691958
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2024-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Chip Thickness and Size on Eating Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003258', 'term': 'Consumer Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satiation: Intake in grams', 'timeFrame': 'Total grams consumed at each 30-minute ad libitum testing session from beginning of eating until end of eating on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.', 'description': 'gram weight of consumption'}, {'measure': 'Satiation: Nutrition', 'timeFrame': 'Total calories consumed at each 30-minute ad libitum testing session from beginning of eating until end of eating on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.', 'description': 'Intake in calories'}, {'measure': 'Duration of eating', 'timeFrame': 'Timed from beginning of eating until end of eating at each 30-minute ad libitum testing sessions on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.', 'description': 'In minutes'}, {'measure': 'Rate of consumption', 'timeFrame': 'Measured in grams per minute at each 30-minute ad libitum testing session from beginning of eating until end of eating, on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.', 'description': 'Speed of eating in minutes'}, {'measure': 'Consumer response: Liking', 'timeFrame': 'At end of eating each product at the one 45-minute sensory session, and at end of each 30-minute ad libitum session on separate days, two visits for the tortilla chips arm and three visits for the extruded chips arm. Higher score is the better outcome.', 'description': '9-point hedonic scale from extremely dislike to extremely like'}, {'measure': 'Consumer response: Satisfaction', 'timeFrame': 'At end of eating each product at the one 45-minute sensory session and at end of each ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm. Higher satisfaction is a better outcome.', 'description': '9-point hedonic scale from extremely dissatisfied to extremely satisfied'}, {'measure': 'Perceived sensory properties (TCATA)', 'timeFrame': 'Over a period of 60 seconds for each product at the one 45-minute sensory session and at each ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.', 'description': 'Using Temporal CATA (TCATA) choose all that apply from list of crunchy, hard, tooth clogging, loose particles, soft, airy melting'}, {'measure': 'Perceived sensory properties (CATA)', 'timeFrame': 'Check all that apply for each product while sampling them at the one 45-minute sensory session. A favorable rating would be a better outcome.', 'description': 'CATA'}, {'measure': 'Emotional responses using CATA', 'timeFrame': 'Check all that apply for each product while sampling them at the one 45-minute sensory session. Positive ratings would be a better outcome than negative..', 'description': 'Essence 25 using CATA'}, {'measure': 'Hunger and Fullness and how much could you eat right now', 'timeFrame': 'Before eating and right after eating as much as they want to eat at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.', 'description': 'Using a 3 item Visual Analog Scale (VAS) to mark along 100 mm line the level of hunger and fullness from not at all to totally full'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sensory testing', 'intake', 'calories', 'duration of eating', 'rate of consumption', 'snack', 'liking', 'satiation', 'chewing', 'emotion', 'satisfaction', 'fullness'], 'conditions': ['Consumer Behavior', 'Consumer Preference', 'Consumer Satisfaction']}, 'descriptionModule': {'briefSummary': 'To analyze prototypes developed with the base and seasonings of products that exhibit variations in chip thickness and size. The information obtained from this analysis will serve as the basis for subsequent research to explore different prototype options with increased satiation properties.', 'detailedDescription': 'There are two study components, a sensory study and an ad libitum study. Eighty-eight participants will test tortilla chips and eighty-eight will test extruded chips in the sensory study. On a first-come first-served basis, forty-four of the eighty-eight chip participants from the sensory testing phase will test tortilla chips, and forty-four of the eighty-eight extruded chip participants will test extruded chips in the ad libitum study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Report eating tortilla and/or extruded chips regularly, non-rejector of cheese flavor chips\n* Provide informed consent\n* Speak and understand English without difficulty\n* Willing to eat similar food the day prior and on the day of each visit to the testing facility for ad libitum sessions\n* Describe yourself as generally healthy\n\nExclusion Criteria:\n\n* Those who are on restricted diet due to a weight loss or maintenance purpose\n* Participants with class III occlusions for ad libitum sessions\n* Have abnormal taste, chewing and smell ability\n* Smoke or vape\n* Being pregnant or breastfeeding\n* Allergic or intolerance to any of the product ingredients (section 6), especially milk and wheat\n* Participation in a sensory clinical trial within past 7 days (we do not expect carryover issue from the taste testing)\n* Participation in any PepsiCo trial within past 6 months'}, 'identificationModule': {'nctId': 'NCT06691958', 'briefTitle': 'Impact of Chip Thickness and Size on Eating Responses', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Impact of Chip Thickness and Size on Eating Responses', 'orgStudyIdInfo': {'id': 'PEP-2409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard tortilla chip for Sensory Study', 'description': 'Snack comparable to marketed version', 'interventionNames': ['Other: Tortilla corn chips 4-5 pieces, eat one piece at time']}, {'type': 'EXPERIMENTAL', 'label': 'Thicker than standard tortilla chip with same amount of seasoning per 100g for Sensory Study', 'description': 'Snack', 'interventionNames': ['Other: Tortilla corn chips 4-5 pieces, eat one piece at time']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard extruded chip for Sensory Study', 'description': 'Snack comparable to marketed version', 'interventionNames': ['Other: Extruded corn chips 4-5 pieces, eat one piece at time']}, {'type': 'EXPERIMENTAL', 'label': 'Bigger extruded chip with same seasoning per 100g for Sensory Study', 'description': 'Snack', 'interventionNames': ['Other: Extruded corn chips 4-5 pieces, eat one piece at time']}, {'type': 'EXPERIMENTAL', 'label': 'Bigger extruded chip with same concentration of seasoning on surface per 100g for Sensory Study', 'description': 'Snack', 'interventionNames': ['Other: Extruded corn chips 4-5 pieces, eat one piece at time']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard tortilla chip for Ad libitum Study', 'description': 'Snack comparable to marketed version', 'interventionNames': ['Other: Tortilla corn chips 90 grams']}, {'type': 'EXPERIMENTAL', 'label': 'Thicker than standard tortilla chip with same seasoning per 100g for Ad libitum Study', 'description': 'Snack', 'interventionNames': ['Other: Tortilla corn chips 90 grams']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard extruded chip for Ad libitum Study', 'description': 'Snack comparable to marketed version', 'interventionNames': ['Other: Extruded corn chips 90 grams']}, {'type': 'EXPERIMENTAL', 'label': 'Bigger extruded chip with same seasoning per 100g for Ad libitum Study', 'description': 'Snack', 'interventionNames': ['Other: Extruded corn chips 90 grams']}, {'type': 'EXPERIMENTAL', 'label': 'Bigger extruded chip with same concentration of seasoning on surface per 100g for Ad libitum Study', 'description': 'Snack', 'interventionNames': ['Other: Extruded corn chips 90 grams']}], 'interventions': [{'name': 'Tortilla corn chips 4-5 pieces, eat one piece at time', 'type': 'OTHER', 'description': 'Snack', 'armGroupLabels': ['Standard tortilla chip for Sensory Study', 'Thicker than standard tortilla chip with same amount of seasoning per 100g for Sensory Study']}, {'name': 'Tortilla corn chips 90 grams', 'type': 'OTHER', 'description': 'Snack', 'armGroupLabels': ['Standard tortilla chip for Ad libitum Study', 'Thicker than standard tortilla chip with same seasoning per 100g for Ad libitum Study']}, {'name': 'Extruded corn chips 90 grams', 'type': 'OTHER', 'description': 'Snack', 'armGroupLabels': ['Bigger extruded chip with same concentration of seasoning on surface per 100g for Ad libitum Study', 'Bigger extruded chip with same seasoning per 100g for Ad libitum Study', 'Standard extruded chip for Ad libitum Study']}, {'name': 'Extruded corn chips 4-5 pieces, eat one piece at time', 'type': 'OTHER', 'description': 'Snack', 'armGroupLabels': ['Bigger extruded chip with same concentration of seasoning on surface per 100g for Sensory Study', 'Bigger extruded chip with same seasoning per 100g for Sensory Study', 'Standard extruded chip for Sensory Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE12 5RD', 'city': 'Sutton Bonington', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'University of Nottingham Sensory Science Centre', 'geoPoint': {'lat': 52.82144, 'lon': -1.24969}}], 'overallOfficials': [{'name': 'Qian Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham, Sensory Science Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}