Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-04-14 @ 9:42 AM
Study NCT ID:
NCT01771094
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sweetness of the Beverage in Thirst Sensation
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': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivational Ratings', 'timeFrame': '1 day', 'description': 'Participants will rate their hunger, thirst, nausea, mouth dryness, desire to eat, desire to drink using nine point category scales. The unipolar adjective scales were anchored at each end with labels: 1 = not at all and 9 = extremely. Participants also rated their perception about beverage sweetness along nine point hedonic preference scales where 1 = no sweet at all and 9 = extremely sweet'}], 'secondaryOutcomes': [{'measure': 'Food Behavior After Intervention', 'timeFrame': '1 day', 'description': 'After lunch, participants will bring a food diary to record all food and fluid intake until 00.00 that day. Then, we will analyse total calories ingested, total fluid ingested and the volume of sugar and sugary beverages ingested.'}, {'measure': 'Physiological Parameters', 'timeFrame': '1 day', 'description': 'Glycaemia, blood osmolality and hydration parameters (total body water, intra and extracellular body water) will be assessed before and after the ingestion of beverages'}, {'measure': 'Amount of water ingested', 'timeFrame': '1 day', 'description': 'After the ingestion of 3 preloads with the beverages in study, the participants will lunch the same meal with free water ingestion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thirst']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if water and diet soft drinks with different levels of sweeteners have the same effect on thirst.', 'detailedDescription': 'Participants should be in the laboratory at 8.00 in order to collect the values of weight, height, total body water, intracellular water and extracellular water in a Segmental Multi Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be collected for analysis of blood glucose and osmolality. They will sit at individual tables for the duration of the session and were allowed to read, listen to music with earphones, or use their portable computers with the exception of internet access to minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will be provided at 13.00. Motivational ratings will be first obtained at the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times 1 through 7). After lunch (time 8), participants will complete the last set of ratings and will bring a food diary to record all food and fluid intake until 00.00 that day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* pregnant and nursing women\n* smokers\n* athletes\n* subjects under medication(except oral contraceptives in women)\n\nInclusion Criteria:\n\n* body mass index(BMI) between (18,5 - 27,5 kg/m2)\n* regular consumers of breakfast\n* stable in weight for the past 6 months\n* not dieting to gain or lose weight\n* like all drinks and food available in study'}, 'identificationModule': {'nctId': 'NCT01771094', 'briefTitle': 'Effect of Sweetness of the Beverage in Thirst Sensation', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Effect of Sweetness of the Beverage in Thirst Sensation', 'orgStudyIdInfo': {'id': 'IHS/FCNAUP-002'}, 'secondaryIdInfos': [{'id': 'Nº30/CEUP/2011'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1 (placebo) - Water', 'description': 'This group will drink water in 1st trial', 'interventionNames': ['Behavioral: Effect of sweetness of the beverage in thirst sensation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (Intervention) - "Low" Sucralose', 'description': 'This group will drink Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage in 1st trial', 'interventionNames': ['Behavioral: Effect of sweetness of the beverage in thirst sensation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2(Intervention)-"High" Sucralose', 'description': 'This group will drink Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage in 1st trial', 'interventionNames': ['Behavioral: Effect of sweetness of the beverage in thirst sensation']}], 'interventions': [{'name': 'Effect of sweetness of the beverage in thirst sensation', 'type': 'BEHAVIORAL', 'description': 'Effect of sweetness of the beverage in thirst sensation:\n\nThe participants will drink Water (control group),"High Sucralose" - Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage, and "Low Sucralose" - Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage. The beverages will be presented chilled but without ice in 500 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min.', 'armGroupLabels': ['Group 1 (placebo) - Water', 'Group 2(Intervention)-"High" Sucralose', 'Group 3 (Intervention) - "Low" Sucralose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-465', 'city': 'Porto', 'state': 'Porto District', 'country': 'Portugal', 'facility': 'Faculty of Nutrition and Food Sciences - University of Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Pedro R Carvalho, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FCNAUP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Invited Assistant', 'investigatorFullName': 'Pedro Miguel Fernandes Ramos de Carvalho', 'investigatorAffiliation': 'Universidade do Porto'}}}}