Study to Explore How Core Temperature Reduction Influence Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Value of weight in kilogram assessed by Seca body weight scale
研究概览
简要总结
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:
- Does cold water drinking lower the body fat percentage?
- 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:
- Drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Those who need to take medication for a long term (including diet pills)
- •On a diet
- •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
结局指标
主要结局
Value of weight in kilogram assessed by Seca body weight scale
时间窗: 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.
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.
Value of body mass index (BMI) calculated by weight and height
时间窗: 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.
BMI will be calculated based on weight and height according to the formula: BMI=Weight/Height\^2
Body composition- volume of fat mass in cm^3 assessed by uMR 790
时间窗: 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.
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.
Value of core body temperature in centigrade assessed by e-Celsius
时间窗: 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.
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.
Value of height in meters assessed by Seca 217 stadiometer
时间窗: 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.
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.
Body composition-weight of fat free mass in gram assessed by Tanita MC-980
时间窗: 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.
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.
Waist circumferences in centimeter assessed by TG2000-F
时间窗: 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 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.
Brown adipose tissue-areas of temperature increase in cm^2 assessed by Fluke RSE600
时间窗: 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.
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.
Body composition-wegiht of fat mass in gram assessed by Horizon Wi
时间窗: 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.
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.
Hip circumferences in centimeter assessed by by TG2000-F
时间窗: 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 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.
次要结局
- 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.)
- Concentration of triglyceride (TG) 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 insulin in mU/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.)
- 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.)
- Concentration of TNF-Alpha in ng/mL 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 High-Density Lipoprotein (HDL) 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 Low-Density Lipoprotein (LDL) 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.)
研究者
John R. Speakman
Prof.
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences