Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-11 @ 10:08 AM
Study NCT ID:
NCT05485168
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intake by weight', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Weight (grams) of all meal components consumed'}, {'measure': 'Change in energy intake', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density'}], 'secondaryOutcomes': [{'measure': 'Change in bite count', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'The number of bites of food during the meal'}, {'measure': 'Change in active eating time', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Duration of the time spent eating in minutes'}, {'measure': 'Change in mean eating rate', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration'}, {'measure': 'Change in mean bite size', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count'}, {'measure': 'Change in sip count', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'The number of sips of water during the meal'}, {'measure': 'Change in mean drinking rate', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration'}, {'measure': 'Change in mean sip size', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count'}, {'measure': 'Change in switching between bites and sips', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'The number of switches between bites and sips during the meal'}, {'measure': 'Change in rating of pleasantness of the taste of food samples', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from not at all pleasant (0 mm) to extremely pleasant (100 mm). This will be used to calculate Sensory-Specific Satiety'}, {'measure': 'Change in rating of desire to eat food samples', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from not at all strong (0 mm) to extremely strong (100 mm), in answer to "How strong is your desire to eat \\[this food\\] right now?". This will be used to calculate Sensory-Specific Satiety.'}, {'measure': 'Change in rating of hunger', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm)'}, {'measure': 'Change in rating of thirst', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm)'}, {'measure': 'Change in rating of nausea', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm)'}, {'measure': 'Change in rating of fullness', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm)'}, {'measure': 'Change in rating of prospective consumption', 'timeFrame': 'Weeks 1, 2, 3, 4', 'description': 'Measured on a 100-mm visual analogue scale ranging from nothing at all (0 mm) to a large amount (100 mm), in answer to "How much food do you think you could eat right now?".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Behavior']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to investigate the combined effects of sequential meal variety and portion size on food intake at a meal. Additionally, other individual characteristics will be examined for their influence on the effects of simultaneous variety and portion size on meal intake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing and able to travel to Penn State University Park campus weekly for meals\n* Be fully vaccinated against COVID-19\n* Be a woman 20 - 65 years old\n* Regularly eat 3 meals/day\n* Be willing to refrain from drinking alcohol the day before and during test days\n* Have a body mass index between 18.0 and 35.0 kg/m\\*m\n* Be willing to refrain from eating after 10 pm the evening before test sessions\n* Be willing to participate in all study procedures\n\nExclusion Criteria:\n\n* Must not be a smoker\n* Must not be an athlete in training\n* Must not be pregnant or breastfeeding at the time of screening\n* Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months\n* Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)\n* Must not have a high variability in liking of the test foods\n* Must not be currently dieting to gain or lose weight\n* Must not have a health condition that affects appetite\n* Must not have participated in a similar study in our lab in the past year\n* Must not be a student, faculty, or staff member in nutritional sciences or psychology'}, 'identificationModule': {'nctId': 'NCT05485168', 'briefTitle': 'Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women', 'orgStudyIdInfo': {'id': 'FoodVariety104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential Variety, Small Portion', 'description': '3 different foods served in a small portion in 3 successive courses', 'interventionNames': ['Other: Sequential Variety', 'Other: Small Portion']}, {'type': 'EXPERIMENTAL', 'label': 'Sequential Variety, Large Portion', 'description': '3 different foods served in a large portion in 3 successive courses', 'interventionNames': ['Other: Sequential Variety', 'Other: Large Portion']}, {'type': 'EXPERIMENTAL', 'label': 'Single-Food, Small Portion', 'description': '1 food served in a small portion in 3 successive courses', 'interventionNames': ['Other: Single-Food', 'Other: Small Portion']}, {'type': 'EXPERIMENTAL', 'label': 'Single-Food, Large Portion', 'description': '1 food served in a large portion in 3 successive courses', 'interventionNames': ['Other: Single-Food', 'Other: Large Portion']}], 'interventions': [{'name': 'Sequential Variety', 'type': 'OTHER', 'description': '3 different foods served in 3 successive courses', 'armGroupLabels': ['Sequential Variety, Large Portion', 'Sequential Variety, Small Portion']}, {'name': 'Single-Food', 'type': 'OTHER', 'description': '1 food served in 3 successive courses', 'armGroupLabels': ['Single-Food, Large Portion', 'Single-Food, Small Portion']}, {'name': 'Small Portion', 'type': 'OTHER', 'description': 'Small meal portion size', 'armGroupLabels': ['Sequential Variety, Small Portion', 'Single-Food, Small Portion']}, {'name': 'Large Portion', 'type': 'OTHER', 'description': 'Large meal portion size', 'armGroupLabels': ['Sequential Variety, Large Portion', 'Single-Food, Large Portion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jenny Craig, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior', 'investigatorFullName': 'Barbara J. Rolls', 'investigatorAffiliation': 'Penn State University'}}}}