Clinical trial NCT05900960: Hot or Cold Beverages in Warm Weather
Official title: Hot or Cold Beverages in Warm Weather: A Double-blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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:

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

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.

Primary outcomes:
measure: Thermal well-being
timeFrame: At 3 minutes after intervention
measure: Mood
timeFrame: At 3 minutes after intervention
measure: Pain, discomfort, depression.
timeFrame: At 3 minutes after intervention
Secondary outcomes:
measure: Temperature
timeFrame: At 3 minutes after intervention
Other outcomes:
Locations:
city: Kusadasi
country: Turkey
facility: Conference hotel
Study officials:
affiliation: University of Copenhagen, Herlev Hospital
name: Viktor FB Moseholm
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen, Herlev Hospital
name: Jacob Rosenberg, Professor
role: STUDY_CHAIR
References: