Hot or Cold Beverages in Warm Weather | NCT05900960

Studies
Hot or Cold Beverages in Warm Weather

NCT05900960

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Jun 18, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Quality of Life

Interventions

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2023Actual

Primary Completion Date

May 10, 2023Actual

Completion Date

May 10, 2023Actual

First Submitted Date

Apr 27, 2023

First Submission Date that Met QC Criteria

Jun 2, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2023

Last Update Posted Date

Jun 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Siv Fonnes, Doctor, Herlev HospitalPrincipal Investigator

Lead Sponsor

Herlev HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

All participants must be adults (18 years or older) and not have a fever on the day of the experiment.

Prior 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.

Walk-through of study:

Participants lie or sit in the sun for 10 minutes without drinking anything.
Then, participants drink their allocated beverage in ≤ 5 sec. while still in the sun.
Approximately 3 minutes (±1 min.) after ingestion of the beverage intervention, participants must answer all questionnaires and have their temperature measured.
Afterward, participants stay in the shade for 5 minutes (wash-out period).
Participants lie down (or sit) in the sun for the second time for 10 minutes without drinking anything.
Then, participants drink their second allocated beverage in ≤ 5 sec. while still in the sun.
Approximately 3 minutes (±1 min.) after ingestion of the second beverage intervention, participants must again answer all questionnaires and have their temperature measured.
Data collection and the research project end thereafter

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Warm tea	Experimental	50 degrees celsius hot tea.	Dietary Supplement: Tea
Cool tea	Active Comparator	10 degrees celsius cool tea	Dietary Supplement: Tea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tea	Dietary Supplement	Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)	Cool tea Warm tea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thermal well-being	Using the Bedford thermal comfort scale and ASHRAE thermal sensation scale (-3 to 3, higher is hotter)	At 3 minutes after intervention
Mood	Using the Brief Mood Introspection Scale (-24 to 24, higher is more positive)	At 3 minutes after intervention
Pain, discomfort, depression.	Using the 5th domain of the EQ-5D-5L (1-5, higher is more pain and/or discomfort, and more depressed)	At 3 minutes after intervention

Secondary Outcomes

Measure	Description	Time Frame
Temperature	Using a forehead thermometer in degrees celsius	At 3 minutes after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Must be able to ingest intervention
Must be able to be in the sun for 2x 13 minutes (using sunscreen and/or other relevant UV protection).

Exclusion Criteria:

Fever on the day of the experiment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Viktor FB Moseholm	University of Copenhagen, Herlev Hospital	Principal Investigator
Jacob Rosenberg, Professor	University of Copenhagen, Herlev Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Conference hotel		Kusadasi			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38084617	Derived	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.

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages