Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT01490034
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Learning and Food Form on Intake in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-09', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy intake', 'timeFrame': '12 weeks', 'description': 'Energy consumed over 12 weeks of intervention.'}, {'measure': 'dietary compensation', 'timeFrame': '12 weeks', 'description': 'spontaneous dietary adjustment in response to intervention'}, {'measure': 'appetite', 'timeFrame': '12 weeks', 'description': 'Effects of intervention on appetitive sensation such as hunger and fullness'}, {'measure': 'effects of learning on energy intake', 'timeFrame': '12 weeks', 'description': 'The effects of learning based on exposure to products that are high or low in energy and liquid or solid'}, {'measure': 'Effects of food form on energy intake', 'timeFrame': '12 weeks', 'description': 'The effects of food form on energy intake before and after chronic exposure to foods varying in food form and energy density'}, {'measure': 'Effects of BMI on sensory learning', 'timeFrame': '12 weeks', 'description': 'The effects of BMI on appetite, energy intake and dietary compensation'}], 'secondaryOutcomes': [{'measure': 'Effects of personality traits on appetite, energy intake and compensation', 'timeFrame': '12 weeks', 'description': 'Effects of personality traits related to feeding on appetite, energy intake and compensation following exposure to foods of different physical form, energy density and before and after learning.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'energy intake', 'appetite', 'food form', 'beverage', 'learning', 'dietary compensation'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24955495', 'type': 'DERIVED', 'citation': 'Jones JB, Mattes RD. Effects of learning and food form on energy intake and appetitive responses. Physiol Behav. 2014 Oct;137:1-8. doi: 10.1016/j.physbeh.2014.06.016. Epub 2014 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive influences, such as cognitive factors, may play a larger role in creating an energy surplus than previously thought. Expectations about the satiating effect of a food may override the post-ingestive influences in dictating further consumption. In addition, obese individuals may exhibit a decreased compensatory response to foods as compared to lean individuals.\n\nUnderstanding the effects of energy content, food form, and learning on satiation, satiety, and energy intake will allow for a greater understanding of the mechanisms of energy imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive effects. By utilizing foods with similar sensory properties, the acquired knowledge derived from ingesting these foods can be monitored by analyzing subsequent intake at the same meal and at subsequent eating occurrences. It is hypothesized that the liquid food form will elicit weaker dietary compensation; that is, energy intake at other eating events will not be adjusted to compensate for that food. In addition, it is posited that the lower energy food will cause lower compensation postprandially. By having participants consume the same test food daily over a two week learning period, it is thought that they will show improved dietary compensation when the initial testing is repeated due to learned associations between food properties and metabolism.', 'detailedDescription': 'No expansion provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight stable (\\<3 kg weight change within last 3 months)\n* Constant habitual activity patterns (no deviation \\> 1x/wk at 30 min/session within last 3 months)\n* Constant habitual diet patterns within last 3 months\n* Willingness to eat a chocolate-flavored snack at test sessions and two week training period\n* No allergies to any test foods\n* Not planning to change use of medications known to influence appetite or metabolism\n* Not diabetic\n* No history of GI pathology\n* Non-smoker for one year or more\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01490034', 'briefTitle': 'Effects of Learning and Food Form on Intake in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Effects of Learning and Food Form on Intake in Humans', 'orgStudyIdInfo': {'id': 'R01DK079913-3'}, 'secondaryIdInfos': [{'id': 'R01DK079913', 'link': 'https://reporter.nih.gov/quickSearch/R01DK079913', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Energy dense beverage', 'description': 'Metabolic effects of consuming energy dense beverages before and after regular consumption', 'interventionNames': ['Behavioral: Metabolic effects of consuming energy dense beverages']}, {'type': 'EXPERIMENTAL', 'label': 'Energy dense solid food form', 'description': 'Metabolic effects of consuming energy dense solid foods before and after regular exposure.', 'interventionNames': ['Behavioral: energy dense solid food']}, {'type': 'EXPERIMENTAL', 'label': 'Eenergy dilute beverages', 'description': 'Metabolic effects of consumption of energy dilute beverages on a regular basis.', 'interventionNames': ['Behavioral: Energy dilute beverages']}, {'type': 'EXPERIMENTAL', 'label': 'Energy dilute solid food form', 'description': 'Metabolic effects of consuming energy dilute sold foods before and after regular exposure.', 'interventionNames': ['Behavioral: Energy dilute solid food']}], 'interventions': [{'name': 'Metabolic effects of consuming energy dense beverages', 'type': 'BEHAVIORAL', 'description': 'Consumption of energy dense beverages for 2 weeks and monitoring physiological responses', 'armGroupLabels': ['Energy dense beverage']}, {'name': 'energy dense solid food', 'type': 'BEHAVIORAL', 'description': 'Effects of consuming energy dense solid food for two weeks on physiological responses', 'armGroupLabels': ['Energy dense solid food form']}, {'name': 'Energy dilute beverages', 'type': 'BEHAVIORAL', 'description': 'Effects of consuming energy dilute beverages for two weeks on physiological responses.', 'armGroupLabels': ['Eenergy dilute beverages']}, {'name': 'Energy dilute solid food', 'type': 'BEHAVIORAL', 'description': 'Effects of consuming energy dilute solid food for two weeks on physiological responses', 'armGroupLabels': ['Energy dilute solid food form']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue Univeristy', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Richard Mattes', 'investigatorAffiliation': 'Purdue University'}}}}