Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-24 @ 10:35 PM
Study NCT ID:
NCT02405494
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hunger and satiety questions (Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)', 'timeFrame': '245 minutes', 'description': 'Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Satiety', 'Appetite']}, 'descriptionModule': {'briefSummary': 'Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of this study is to test the individual contribution, and possible interaction, of the liquid volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x \\[gas volume/liquid volume\\]) of a beverage to its satiating properties.', 'detailedDescription': 'It is not known how the liquid and gas volumes of a liquid foam contribute to its satiating properties and how and if these factors interact. The best way to assess these parameter combinations and their interactions is to use a special statistical approach named "Response Surface Methodology" (RSM). The current study therefore has a Central Composite Design with 9 foams differing in liquid volume and in ratio of gas to liquid volume (%overrun, which is defined as 100 x gas volume/liquid volume).\n\nEach subject will be appointed to a single parameter combination and receives this parameter combination twice, separated by a one-week wash-out period.\n\nOn both test days subjects\' self-assessment of feelings of satiety and physical discomfort will be recorded during 4 hours post-consumption of the treatment using Electronic Visual Analogue Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 21 and 32 kg/m²\n* Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders\n* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian.\n* Reported intense sporting activities below 10h/w\n* Reported alcohol consumption below 14 units/w (female volunteers) or below 21 units/w (male volunteers)\n\nExclusion Criteria:\n\n* Dislike, allergy or intolerance to test products or indicating to be unable to consume 514 ml of aerated test product\n* Any food allergy, or dislike or intolerance with the foods supplied during the study\n* Eating disorder (measured by SCOFF questionnaire, 2 or more"yes" responses) High or very high restrained eaters (measured by questionnaire; score of 15 or higher, Polivy et al. 1978)\n* Reported medical treatment that may affect eating habits/satiety\n* Reported lactating (or lactating \\< 6 weeks ago), pregnant (or pregnant \\< 6 months ago) or wish to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT02405494', 'briefTitle': 'Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety: a Response-surface-model Study', 'orgStudyIdInfo': {'id': '10029V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Beverage 1', 'description': 'Liquid foam consisting of 37 ml liquid with 73% overrun (total volume 65 ml).', 'interventionNames': ['Dietary Supplement: Beverage 1']}, {'type': 'OTHER', 'label': 'Beverage 2', 'description': 'Liquid foam consisting of 37 ml liquid with 427% overrun (total volume 197 ml).', 'interventionNames': ['Dietary Supplement: Beverage 2']}, {'type': 'OTHER', 'label': 'Beverage 3', 'description': 'Liquid foam consisting of 98 ml liquid with 73% overrun (total volume 169 ml).', 'interventionNames': ['Dietary Supplement: Beverage 3']}, {'type': 'OTHER', 'label': 'Beverage 4', 'description': 'Liquid foam consisting of 98 ml liquid with 427% overrun (total volume 514 ml).', 'interventionNames': ['Dietary Supplement: Beverage 4']}, {'type': 'OTHER', 'label': 'Beverage 5', 'description': 'Liquid foam consisting of 25 ml liquid with 250% overrun (total volume 88 ml).', 'interventionNames': ['Dietary Supplement: Beverage 5']}, {'type': 'OTHER', 'label': 'Beverage 6', 'description': 'Liquid foam consisting of 110 ml liquid with 250% overrun (total volume 385 ml).', 'interventionNames': ['Dietary Supplement: Beverage 6']}, {'type': 'OTHER', 'label': 'Beverage 7', 'description': '68 ml beverage consisting of 68 ml liquid with 0% overrun (total volume 68 ml).', 'interventionNames': ['Dietary Supplement: Beverage 7']}, {'type': 'OTHER', 'label': 'Beverage 8', 'description': 'Liquid foam consisting of 68 ml liquid with 500% overrun (total volume 405 ml).', 'interventionNames': ['Dietary Supplement: Beverage 8']}, {'type': 'OTHER', 'label': 'Beverage 9', 'description': 'Liquid foam consisting of 68 ml liquid with 250% overrun (total volume 236 ml).', 'interventionNames': ['Dietary Supplement: Beverage 9']}], 'interventions': [{'name': 'Beverage 1', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 1']}, {'name': 'Beverage 2', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 2']}, {'name': 'Beverage 3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 3']}, {'name': 'Beverage 4', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 4']}, {'name': 'Beverage 5', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 5']}, {'name': 'Beverage 6', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 6']}, {'name': 'Beverage 7', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 7']}, {'name': 'Beverage 8', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 8']}, {'name': 'Beverage 9', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beverage 9']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leatherhead', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Leatherhead Food Research', 'geoPoint': {'lat': 51.29652, 'lon': -0.3338}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}