跳至主要内容
临床试验/NCT05900960
NCT05900960已完成不适用

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

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Thermal well-being

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Fever on the day of the experiment.

结局指标

主要结局

Thermal well-being

时间窗: At 3 minutes after intervention

Using the Bedford thermal comfort scale and ASHRAE thermal sensation scale (-3 to 3, higher is hotter)

Mood

时间窗: At 3 minutes after intervention

Using the Brief Mood Introspection Scale (-24 to 24, higher is more positive)

Pain, discomfort, depression.

时间窗: 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)

次要结局

  • Temperature(At 3 minutes after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siv Fonnes

Doctor

Herlev Hospital

研究点 (1)

Loading locations...

相似试验