Hot or Cold Beverages in Warm Weather

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Dietary supplement: Tea

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kusadasi, Turkey
    • Conference hotel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm tea; 50 degrees celsius hot tea.	Dietary supplement: Tea; Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)
Active Comparator: Cool tea; 10 degrees celsius cool tea	Dietary supplement: Tea; Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Viktor FB Moseholm, University of Copenhagen, Herlev Hospital; Study Chair: Jacob Rosenberg, Professor, University of Copenhagen, Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: F-23023485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No