Quality of LifeNCT05900960
Hot or Cold Beverages in Warm Weather
A study testing Tea in people with Quality of Life, run by Herlev Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2023to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Fever on the day of the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Quality of Life
- Being tested
- Tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeaDietary supplement
Orally administered. Decaffeinated tea, with no additives (sugar, honey, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Warm tea | Experimental | 50 degrees celsius hot tea. Receives: Dietary Supplement: Tea |
| Cool tea | Active comparator | 10 degrees celsius cool tea Receives: Dietary Supplement: Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal well-being
Using the Bedford thermal comfort scale and ASHRAE thermal sensation scale (-3 to 3, higher is hotter)
Measured: At 3 minutes after intervention
Mood
Using the Brief Mood Introspection Scale (-24 to 24, higher is more positive)
Measured: 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)
Measured: At 3 minutes after intervention
Secondary outcomes (1)
Temperature
Using a forehead thermometer in degrees celsius
Measured: At 3 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start9 May 2023
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siv Fonnes, Herlev Hospital
- Investigators
- Viktor FB Moseholm, Principal investigator, University of Copenhagen, Herlev HospitalJacob Rosenberg, Professor, Study chair, University of Copenhagen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900960
- Sponsor's protocol ID
- F-23023485
- Status last verified
- Jun 2023
- First submitted
- 27 Apr 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38084617
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot or Cold Beverages in Warm Weather: A Double-blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05900960
- Acronym / sponsor ID
- F-23023485
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm tea | Experimental | Dietary Supplement: Tea50 degrees celsius hot tea. |
| Cool tea | Active comparator | Dietary Supplement: Tea10 degrees celsius cool tea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Fever on the day of the experiment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeaOrally administered. Decaffeinated tea, with no additives (sugar, honey, etc.) | Dietary supplement | Cool tea, Warm tea |
Primary outcome
Thermal well-being
Time frame: At 3 minutes after intervention
Using the Bedford thermal comfort scale and ASHRAE thermal sensation scale (-3 to 3, higher is hotter)
Mood
Time frame: At 3 minutes after intervention
Using the Brief Mood Introspection Scale (-24 to 24, higher is more positive)
Pain, discomfort, depression.
Time frame: At 3 minutes after intervention
Using the 5th domain of the EQ-5D-5L (1-5, higher is more pain and/or discomfort, and more depressed)
1 secondary outcome
Temperature
Time frame: At 3 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 38084617Moseholm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor FB Moseholm principal investigator
University of Copenhagen, Herlev Hospital
Jacob Rosenberg, Professor study chair
University of Copenhagen, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea in people with Quality of Life, run by Herlev Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal well-being (time frame: At 3 minutes after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.