Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:49 PM
Study NCT ID:
NCT01770327
Status:
COMPLETED
Last Update Posted:
2013-01-21
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Different Sugary Beverages on Thirst Sensation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', '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.\n\nParticipants also rated their liking for the beverage along nine point hedonic preference scales where 1 = dislike extremely and 9 = like extremely.'}], 'secondaryOutcomes': [{'measure': 'Glycaemia', 'timeFrame': '1 day', 'description': 'Glycaemia 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.'}, {'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': 'Blood osmolality', 'timeFrame': '1 day', 'description': 'Blood osmolality will be assessed before and after the ingestion of beverages'}, {'measure': 'Plasmatic Sodium', 'timeFrame': '1 day', 'description': 'Plasmatic sodium will be measured before and after the ingestion of the beverages.'}, {'measure': 'Hydration parameters', 'timeFrame': '1 day', 'description': 'Total body water, intra and extracellular body water will me measured before and after the ingestion of the beverages'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thirst']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if water and three different sugary beverages (milk, Orange juice and iced tea) 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, osmolality and plasmatic sodium. 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': 'Inclusion 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\n\nExclusion Criteria:\n\n* pregnant and nursing women\n* smokers\n* athletes\n* subjects under medication(except oral contraceptives in women)'}, 'identificationModule': {'nctId': 'NCT01770327', 'briefTitle': 'Influence of Different Sugary Beverages on Thirst Sensation', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Influence of Different Sugary Beverages on Thirst Sensation', 'orgStudyIdInfo': {'id': 'EHI-FCNAUP'}, 'secondaryIdInfos': [{'id': 'Nº30/CEUP/2011_2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1 (placebo) - Water', 'description': 'This group will drink water in 1st trial', 'interventionNames': ['Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Intervention) - Milk', 'description': 'This group will drink Non-Fat Milk in 1st trial', 'interventionNames': ['Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (Intervention) - Orange Juice', 'description': 'This group will drink Orange Juice in 1st trial', 'interventionNames': ['Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 (Intervention) - Iced Tea', 'description': 'This group will drink Iced Tea in 1st study', 'interventionNames': ['Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation']}], 'interventions': [{'name': 'Effect of ingestion of different Sugary Beverages on Thirst Sensation', 'type': 'BEHAVIORAL', 'description': 'The participants will drink Water (control group),Non-fat Milk, Orange Juice and Iced Tea. The beverages will be presented chilled but without ice in 330 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) - Milk', 'Group 3 (Intervention) - Orange Juice', 'Group 4 (Intervention) - Iced Tea']}]}, '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'}}}}