Hot or Cold Beverages in Warm Weather

Quality of Life Clinical Trial

Official title:

Hot or Cold Beverages in Warm Weather: A Double-blinded Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900960
• Other study ID #: F-23023485
• Status: Completed
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: May 10, 2023

Study information

• Verified date: June 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Dietary Supplement:
• Tea
Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)

Locations

Country	Name	City	State
Turkey	Conference hotel	Kusadasi

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mood	Using the Brief Mood Introspection Scale (-24 to 24, higher is more positive)	At 3 minutes after intervention
Primary	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	Temperature	Using a forehead thermometer in degrees celsius	At 3 minutes after intervention