NCT05900960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 9, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1 day

First QC Date

April 27, 2023

Last Update Submit

June 15, 2023

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Temperature

    At 3 minutes after intervention

Study Arms (2)

Warm tea

EXPERIMENTAL

50 degrees celsius hot tea.

Dietary Supplement: Tea

Cool tea

ACTIVE COMPARATOR

10 degrees celsius cool tea

Dietary Supplement: Tea

Interventions

TeaDIETARY_SUPPLEMENT

Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)

Cool teaWarm tea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Fever on the day of the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Conference hotel

Kusadasi, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 38084617DERIVED

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Viktor FB Moseholm

    University of Copenhagen, Herlev Hospital

    PRINCIPAL INVESTIGATOR

  • Jacob Rosenberg, Professor

    University of Copenhagen, Herlev Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 27, 2023

First Posted

June 13, 2023

Study Start

May 9, 2023

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)