Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:00 AM
Study NCT ID:
NCT05900960
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hot or Cold Beverages in Warm Weather
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thermal well-being', 'timeFrame': 'At 3 minutes after intervention', 'description': 'Using the Bedford thermal comfort scale and ASHRAE thermal sensation scale (-3 to 3, higher is hotter)'}, {'measure': 'Mood', 'timeFrame': 'At 3 minutes after intervention', 'description': 'Using the Brief Mood Introspection Scale (-24 to 24, higher is more positive)'}, {'measure': 'Pain, discomfort, depression.', 'timeFrame': 'At 3 minutes after intervention', 'description': 'Using the 5th domain of the EQ-5D-5L (1-5, higher is more pain and/or discomfort, and more depressed)'}], 'secondaryOutcomes': [{'measure': 'Temperature', 'timeFrame': 'At 3 minutes after intervention', 'description': 'Using a forehead thermometer in degrees celsius'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'referencesModule': {'references': [{'pmid': '38084617', 'type': 'DERIVED', 'citation': 'Moseholm VB, Reistrup H, Rosenberg J, Fonnes S. Christmas article: Well-being in hot weather - a randomised crossover trial. Ugeskr Laeger. 2023 Dec 11;185(50):V20239. Danish.'}]}, 'descriptionModule': {'briefSummary': 'Some studies have suggested that hot beverages are better for cooling down when body temperature rises. No study has investigated the effect of hot beverages in hot weather on personal well-being compared to cold beverages.', 'detailedDescription': "The research project will be conducted as a double-blinded randomized crossover trial, where the participants will drink either 10 cl of 10°C cold tea (±2°C) or 50°C hot tea (±2°C), which in a pilot study and in the literature \\[1,9\\] has been shown to be without discomfort or side effects. The order of the two interventions will be randomized.\n\nAll participants must be adults (18 years or older) and not have a fever on the day of the experiment.\n\nPrior to participation, participants must provide written informed consent and must show up in clothing they find comfortable in the sun and be wearing sunscreen and a sun hat/cap. Participants must also complete a questionnaire on basic background information: gender, age, height, weight, clothing during the trial, and the participant's preference regarding the climate and temperature of beverages.\n\nWalk-through of study:\n\n1. Participants lie or sit in the sun for 10 minutes without drinking anything.\n2. Then, participants drink their allocated beverage in ≤ 5 sec. while still in the sun.\n3. Approximately 3 minutes (±1 min.) after ingestion of the beverage intervention, participants must answer all questionnaires and have their temperature measured.\n4. Afterward, participants stay in the shade for 5 minutes (wash-out period).\n5. Participants lie down (or sit) in the sun for the second time for 10 minutes without drinking anything.\n6. Then, participants drink their second allocated beverage in ≤ 5 sec. while still in the sun.\n7. Approximately 3 minutes (±1 min.) after ingestion of the second beverage intervention, participants must again answer all questionnaires and have their temperature measured.\n8. Data collection and the research project end thereafter"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Must be able to ingest intervention\n* Must be able to be in the sun for 2x 13 minutes (using sunscreen and/or other relevant UV protection).\n\nExclusion Criteria:\n\n* Fever on the day of the experiment.'}, 'identificationModule': {'nctId': 'NCT05900960', 'briefTitle': 'Hot or Cold Beverages in Warm Weather', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Hot or Cold Beverages in Warm Weather: A Double-blinded Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'F-23023485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Warm tea', 'description': '50 degrees celsius hot tea.', 'interventionNames': ['Dietary Supplement: Tea']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cool tea', 'description': '10 degrees celsius cool tea', 'interventionNames': ['Dietary Supplement: Tea']}], 'interventions': [{'name': 'Tea', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)', 'armGroupLabels': ['Cool tea', 'Warm tea']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kusadasi', 'country': 'Turkey (Türkiye)', 'facility': 'Conference hotel', 'geoPoint': {'lat': 37.86014, 'lon': 27.25713}}], 'overallOfficials': [{'name': 'Viktor FB Moseholm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen, Herlev Hospital'}, {'name': 'Jacob Rosenberg, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Copenhagen, Herlev Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Siv Fonnes', 'investigatorAffiliation': 'Herlev Hospital'}}}}