Clinical trial NCT06432491: The Association Between Core Temperature and Health
Official title: Study to Explore How Core Temperature Reduction Influence Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Body Temperature Changes
Body Composition
Aging
Keywords: Body temperature
Body composition
Aging
Lead sponsor: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Shenzhen University General Hospital
name: The Hong Kong Polytechnic University
First posted: 2024-05-29
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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. 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.

Detailed description: According to pilot study, we found 4℃ water could significantly reduce core body temperature. Thus, we aim to explore whether 4℃ water drinking could promote body composition and further help to extend lifespan.

Participants will be randomly divided into intervention (drinking 4℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) and control group (drinking 37℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) for 6-month intervention. Tests will be conducted in Shenzhen Institute of Advanced Technology, while checkup will be tested at Health Checkup Department of Shenzhen University General Hospital. Body composition will be tested by Magnetic Resonance Imaging (MRI), Dual-Energy X-Ray Absorptiometry (DEXA), and TANITA (bioelectrical method). In addition, we will test participants' waist and hip circumferences using 3D scanning. Besides, we will test core body temperature and brown adipose tissue.

Apart from above main outcomes, we will also test their physical activity, food intake, metabolic rate, glucose, IL-6, TNF-alpha, HDL, LDL, insulin level. Meanwhile, ageing biomarkers, namely Phenotypic Age, eye fundus image, facial changes, bone density, gut microbiota, GlycanAge, will also be measured.

The whole intervention period will last for 6 months. All the tests and checkup will be tested at baseline, the end of the third month and the endpoint of the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Value of core body temperature in centigrade assessed by e-Celsius
timeFrame: 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.
measure: Value of weight in kilogram assessed by Seca body weight scale
timeFrame: 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.
measure: Value of height in meters assessed by Seca 217 stadiometer
timeFrame: 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.
measure: Value of body mass index (BMI) calculated by weight and height
timeFrame: 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.
measure: Body composition- volume of fat mass in cm^3 assessed by uMR 790
timeFrame: 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.
measure: Body composition-weight of fat free mass in gram assessed by Tanita MC-980
timeFrame: 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.
measure: Body composition-wegiht of fat mass in gram assessed by Horizon Wi
timeFrame: 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.
measure: Waist circumferences in centimeter assessed by TG2000-F
timeFrame: 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.
measure: Hip circumferences in centimeter assessed by by TG2000-F
timeFrame: 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.
measure: Brown adipose tissue-areas of temperature increase in cm^2 assessed by Fluke RSE600
timeFrame: 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:
measure: Intensity of physical activity in three types (light, moderate, vigorous) assessed by GT3X
timeFrame: 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.
measure: Weight of food intake in gram assessed by 24-hour Dietary Review Questionnaire
timeFrame: 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.
measure: Resting metabolic rate in kcal assessed by Cosmed
timeFrame: 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.
measure: Concentration of glucose in mmol/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of IL-6 in ng/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of TNF-Alpha in ng/mL assessed by clinical blood test
timeFrame: 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.
measure: Concentration of High-Density Lipoprotein (HDL) in mmol/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of Low-Density Lipoprotein (LDL) in mmol/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of triglyceride (TG) in mmol/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of insulin in mU/L assessed by clinical blood test
timeFrame: 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:
measure: Concentration of albumin in g/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of creatinine in umol/L assessed by clinical blood test
timeFrame: 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.
measure: Concentration of C-reactive protein in mg/dL assessed by clinical blood test
timeFrame: 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.
measure: Percentage of lymphocyte assessed by clinical blood test
timeFrame: 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.
measure: Volume of mean (red) cell assessed by clinical blood test
timeFrame: 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.
measure: Coefficient of variation of red blood cell size (red cell distribution width) assessed by clinical blood test
timeFrame: 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.
measure: Concentration of alkaline phosphatase in U/L assessed by clinical blood test
timeFrame: 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.
measure: Number of white blood cell (white blood cell count) in 1000 cells/uL assessed by clinical blood test
timeFrame: 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.
measure: Calculation of Phenotypic Age based on blood test
timeFrame: The calculation will cost 5 minutes. The calculation will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
measure: Bone density in g/cm^2 assessed by Horizon Wi
timeFrame: 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.
measure: Eye fundus imaging assessed by Spectralis OCT
timeFrame: 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.
measure: Picture of facial features assessed by Fluke RSE600
timeFrame: 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.
measure: Muscle strength in kilogram assessed by Jamar Plus+ Digital Hand Dynamometer
timeFrame: Ten 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.
measure: Microbiome assessed by Illumina
timeFrame: Feces will be collected by volunteers themselves and send to the researchers. Feces will be collected at baseline, the end of the 3rd month, and the end of the 6th month.
measure: Score of GlycanAge assessed by GlycanAge kit
timeFrame: Ten 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.
Locations:
city: Shenzhen
country: China
facility: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
state: Guangdong
Study officials:
affiliation: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
name: John R Speakman, PhD
role: STUDY_CHAIR
References: