Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05152693
Status:
WITHDRAWN
Last Update Posted:
2021-12-10
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Variety and Portion Size on Meal Intake of Adults
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001628', 'term': 'Beverages'}], '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study design has changed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-01-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intake by weight', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6', 'description': 'Weight (grams) of all meal components consumed'}, {'measure': 'Change in energy intake', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6', '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, 5, 6', 'description': 'The number of bites of food during the meal'}, {'measure': 'Change in meal duration', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6', 'description': 'Duration of the meal in minutes'}, {'measure': 'Change in mean eating rate', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6', '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, 5, 6', '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, 5, 6', 'description': 'The number of sips of water during the meal'}, {'measure': 'Change in mean drinking rate', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6', '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, 5, 6', '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, 5, 6', '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': 'From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6', '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 prospective consumption of food samples', 'timeFrame': 'From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': 'Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) how much of \\[this food\\] do you want to eat right now?. This will be used to calculate Sensory-Specific Satiety'}, {'measure': 'Change in rating of hunger', 'timeFrame': 'From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6', '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': 'From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6', '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': 'From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6', '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': 'From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6', '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 of the meal', 'timeFrame': 'At the start of the test meal in weeks 1, 2, 3, 4, 5, 6', '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 the question 'How much food could you eat right now?'."}, {'measure': "Change in rating of the size of the meal compared to participant's usual portion", 'timeFrame': 'At the start of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from a lot smaller (0 mm) to a lot larger (100 mm)'}, {'measure': 'Change in rating of how filling the participant expects this amount of food to be', 'timeFrame': 'At the start of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from not at all filling (0 mm) to extremely filling (100 mm)'}, {'measure': 'Change in rating of meal termination due to fullness', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)'}, {'measure': 'Change in rating of meal termination due to eating their usual amount', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)'}, {'measure': 'Change in rating of meal termination due to eating is no longer a priority', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)'}, {'measure': 'Change in rating of meal termination due to there being no food left', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)'}, {'measure': 'Change in rating of meal termination due to self-consciousness about amount consumed', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)'}, {'measure': 'Change in rating of meal termination due to the food no longer tasting good', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)'}, {'measure': 'Change in estimation of proportion of meal eaten', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': '100-point visual analog scale ranging from 0% to 100%'}, {'measure': 'Change in estimation of calories consumed at the meal', 'timeFrame': 'At the end of the test meal in weeks 1, 2, 3, 4, 5, 6', 'description': 'Open ended question (number of calories)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Behavior']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to gain a better understanding of the combined effects of meal variety and portion size on food intake at a meal. The study will also explore relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of 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 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': 'NCT05152693', 'briefTitle': 'Effects of Variety and Portion Size on Meal Intake of Adults', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Effects of Variety and Portion Size on Meal Intake of Adults', 'orgStudyIdInfo': {'id': 'FoodVariety101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Variety Small Portion Without Beverage', 'description': 'Test meal with food components mixed together (low variety) with a small portion of food served without water', 'interventionNames': ['Other: Low variety', 'Other: Small Portion Size', 'Other: Without Beverage']}, {'type': 'EXPERIMENTAL', 'label': 'High Variety Small Portion Without Beverage', 'description': 'Test meal with food components separated on the plate (high variety) with a small portion of food served without water', 'interventionNames': ['Other: High Variety', 'Other: Small Portion Size', 'Other: Without Beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Low Variety Small Portion With Beverage', 'description': 'Test meal with food components mixed together (low variety) with a small portion of food and water', 'interventionNames': ['Other: Low variety', 'Other: Small Portion Size', 'Other: With Beverage']}, {'type': 'EXPERIMENTAL', 'label': 'High Variety Small Portion With Beverage', 'description': 'Test meal with food components separated on the plate (high variety) with a small portion of food and water', 'interventionNames': ['Other: High Variety', 'Other: Small Portion Size', 'Other: With Beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Low Variety Large Portion With Beverage', 'description': 'Test meal with food components mixed together (low variety) with a large portion of food and water', 'interventionNames': ['Other: Low variety', 'Other: Large Portion Size', 'Other: With Beverage']}, {'type': 'EXPERIMENTAL', 'label': 'High Variety Large Portion With Beverage', 'description': 'Test meal with food components separated on the plate (high variety) with a large portion of food and water', 'interventionNames': ['Other: High Variety', 'Other: Large Portion Size', 'Other: With Beverage']}], 'interventions': [{'name': 'Low variety', 'type': 'OTHER', 'description': 'Meal components are mixed together on the plate', 'armGroupLabels': ['Low Variety Large Portion With Beverage', 'Low Variety Small Portion With Beverage', 'Low Variety Small Portion Without Beverage']}, {'name': 'High Variety', 'type': 'OTHER', 'description': 'Meal components are served separately on the plate', 'armGroupLabels': ['High Variety Large Portion With Beverage', 'High Variety Small Portion With Beverage', 'High Variety Small Portion Without Beverage']}, {'name': 'Small Portion Size', 'type': 'OTHER', 'description': 'Small meal portion size', 'armGroupLabels': ['High Variety Small Portion With Beverage', 'High Variety Small Portion Without Beverage', 'Low Variety Small Portion With Beverage', 'Low Variety Small Portion Without Beverage']}, {'name': 'Large Portion Size', 'type': 'OTHER', 'description': 'Large meal portion size', 'armGroupLabels': ['High Variety Large Portion With Beverage', 'Low Variety Large Portion With Beverage']}, {'name': 'With Beverage', 'type': 'OTHER', 'description': 'Meal served with water', 'armGroupLabels': ['High Variety Large Portion With Beverage', 'High Variety Small Portion With Beverage', 'Low Variety Large Portion With Beverage', 'Low Variety Small Portion With Beverage']}, {'name': 'Without Beverage', 'type': 'OTHER', 'description': 'Meal served without water', 'armGroupLabels': ['High Variety Small Portion Without Beverage', 'Low Variety Small Portion Without Beverage']}]}, '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'}}}}