The Association Between Core Temperature and Health

ConditionsBody Temperature Changes Body Composition Aging

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-65

SponsorShenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

About this trial

The goal of this clinical trial is to learn if cold water drinking could promote body composition and further extend healthy lifespan in Chinese older adults. The main questions it aims to answer are:

1. Does cold water drinking lower the body fat percentage? 2. Will cold water drinking positively extend lifespan in a long-term Researchers will compare cold water intervention group to a control group (drinking 37℃ water instead) to see if cold water drinking works to promote health and slow down ageing process.

Participants will:

1. Drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months. 2. Visit the institute and health checkup department for tests and checkup at baseline, the end of the 3rd month, and the end of 6th month.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 50 and 65 years old (including 50 and 65)

No surgery in the past 6 months

Healthy (No metabolic diseases, cardiovascular diseases, lung diseases (COPD, asthma, et al.), endocrine diseases and gastrointestinal diseases)

Based in Shenzhen during the whole study period

Disqualifiers

Those who need to take medication for a long term (including diet pills)

On a diet

Disabled

Females who are trying to get pregnant, pregnant, or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

Drinking cold water
Behavioral
Volunteers in the intervention group will be asked to drink up 500 ml 4℃ water within 10 minutes four times per day throughout the study.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: 4℃ water drinking groupExperimental treatment 1 intervention

Group B: 37℃ water drinking groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Value of core body temperature in centigrade assessed by e-Celsius

Volunteers will swallow an electronic capsule called e-Celsius (BodyCap, France) which will be activated before use. Four hours after swallowing, the e-Celsius will enter intestine and data collection will start. A device call e-Viewer (KIT EPERF CE-SW, France) will be used to connect the capsules and collect data.

Time frame

Twenty-four hours every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.

Value of weight in kilogram assessed by Seca body weight scale

Volunteers will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes.

Time frame

Five minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.

Value of height in meters assessed by Seca 217 stadiometer

Measured by Seca 217 Stable Stadiometer. Volunteers should not wear shoes and socks. Stand on the stadiometer platform with back against the wall and feet together. Stand up as straight as possible with heels, back, shoulders, and head all touching the wall. Tuck in chin and look straight ahead.

Time frame

Five minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.

Value of body mass index (BMI) calculated by weight and height

BMI will be calculated based on weight and height according to the formula: BMI=Weight/Height\^2

Time frame

The calculation will cost two minutes every three months for the 6 months of the experiments.The calculation will be collected at baseline, the end of the 3rd month, and the end of the 6th month.

Secondary outcomes

Intensity of physical activity in three types (light, moderate, vigorous) assessed by GT3X

Physical activity of the volunteers will be recorded using accelerometer (GT3X) worn near the hip for a consecutive period of 7 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days. The acceleration of three axises will be collected and then calculated into the intensity of physical activity.

Time frame

Seven days every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.

Weight of food intake in gram assessed by 24-hour Dietary Review Questionnaire

Food intake was monitored using the 24-hour Dietary Review questionnaire (a retrospective record of food intake (quantity and frequency) over the past 24 hours using a self-reported questionnaire).

Time frame

One day every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month.

Resting metabolic rate in kcal assessed by Cosmed

Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The volunteer attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and CO2 production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.

Time frame