The Association Between Core Temperature and Health

NCT06432491 | Recruiting

• 1 other identifier: KYLLHS-20240201A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does cold water drinking lower the body fat percentage?
2. 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.
3. 3.Drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months.
4. 4.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.

Conditions

Aging; Body Temperature Changes; Body Composition

Keywords

Body temperature; Body composition; Aging

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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

  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.

• Body composition- volume of fat mass in cm^3 assessed by uMR 790

  Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). Volunteers should wear no metal jewelries or with metal implants. They should lie down on a movable table and be fasten by technologists. Volunteers should hold still during the test and perform a few small tasks, such as exhale, inhale, and hold breath following the broadcast.

  Fifteen 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.

• Body composition-weight of fat free mass in gram assessed by Tanita MC-980

  Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980). Demographic information of volunteers should be entered before test, including ID number, sex, age, height. When the signal showing the machine is ready, volunteers should stand on the scale without shoes, socks or any pieces which might influence weight. According to the instruction of display screen, volunteers need to hold the handle tightly.

  Fifteen 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.

• Body composition-wegiht of fat mass in gram assessed by Horizon Wi

  Fat free mass will be measured by DEXA (Horizon Wi). Volunteers will be asked to lie on a special DEXA x-ray table. The technologist will help position your correctly and use positioning devices such as foam blocks to help hold the desired position. As the arm of the DEXA machine passes over the body, IT uses two different x-ray beams. The beams use very little radiation to keep the test safer, and help to distinguish bone from other tissues. The scanner translates the bone density measurement data into pictures and graphs. Bone is most easily seen in white, while the, fat and muscle tissue look like shadows in the background on the technologist's computer monitor.

  Fifteen 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.

• Waist circumferences in centimeter assessed by TG2000-F

  Waist circumferences will be measured using a whole body laser scanner (TG2000-F). Volunteers should wear tight underwear during test and stand in front of the machine according to the stickers of instruction. Do some small movement according to instruction.

  Fifteen 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.

• Hip circumferences in centimeter assessed by by TG2000-F

  Hip circumferences will be measured using a whole body laser scanner (TG2000-F). Volunteers should wear tight underwear during test and stand in front of the machine according to the stickers of instruction. Do some small movement according to instruction.

  Fifteen 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.

• Brown adipose tissue-areas of temperature increase in cm^2 assessed by Fluke RSE600

  The infrared thermal imager (Fluke RSE600) will be used to measure brown adipose tissue around clavicle. Each subject was in a relaxed "steady-state" within a familiar environment. They were seated in an upright posture, with arms adducted and with head, neck, and shoulders unclothed, in the center of the study room, away from all heat-emitting objects and 1.0 m away from a thermal imaging camera fixed on a tripod at a set distance, 1 m, from the floor. This positioning ensured comfort as well as the optimum position for visualization of the supraclavicular BAT depots. 5 images were taken at 1-minute intervals before each thermal challenge and represented the control period. Each subject then placed 1hand into cool tap water (20℃).The increase in temperature in the thermal area in the supraclavicular region was further collected.

  Fifteen 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.

Secondary Outcomes (10)

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

  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

  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

  Fifteen minutes of blood test 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.

• Concentration of glucose in mmol/L assessed by clinical blood test

  Fifteen minutes of blood test 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.

• Concentration of IL-6 in ng/L assessed by clinical blood test

  Fifteen minutes of blood test 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.

Other Outcomes (15)

• Concentration of albumin in g/L assessed by clinical blood test

  Fifteen minutes of blood test 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.

• Concentration of creatinine in umol/L assessed by clinical blood test

  Fifteen minutes of blood test 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.

• Concentration of C-reactive protein in mg/dL assessed by clinical blood test

  Fifteen minutes of blood test 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.

Study Arms (2)

4℃ water drinking group

EXPERIMENTAL

Volunteers will drink 500ml 4℃ water within 10 minutes at 9a.m., 12p.m., 15p.m., 18p.m. everyday for 6 months.

Behavioral: Drinking cold water

37℃ water drinking group

NO INTERVENTION

Volunteers will drink 500ml 37℃ water within 10 minutes at 9a.m., 12p.m., 15p.m., 18p.m. everyday for 6 months.

Interventions

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.

4℃ water drinking group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No significant change on body weight in the past 3 months

You may not qualify if:

• 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
• Presence of a metal implant in the body (e.g. pacemaker)
• Those with claustrophobia
• Those with blood phobia, pathological hypotension or hypertension
• Those who are in other intervention studies

Sponsors & Collaborators

• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: lead
• Shenzhen University General Hospital: collaborator
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

Shenzhen, Guangdong, 518055, China

RECRUITING

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John R Speakman, PhD

  Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

  STUDY CHAIR

Central Study Contacts

John R Speakman, PhD

CONTACT

15810868669; j.speakman@abdn.ac.uk

Yinuo Wang, Master

CONTACT

15734075325; yi-nuo.wang@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All the participants will only get access to their own group and will not get access to other group members. The investigator who take charge of MRI test for participants' body composition will not have any idea about grouping.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Participants will be randomly divided into intervention group and control group. Intervention group will drink 4℃ water while control group will drink 37℃ water for 6 months.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 29, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)