The Association Between Core Temperature and Health

Официальное название

Study to Explore How Core Temperature Reduction Influence Health

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Drinking cold water
  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.

Первичные конечные точки

• Value of core body temperature in centigrade assessed by e-Celsius [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (10)

• Intensity of physical activity in three types (light, moderate, vigorous) assessed by GT3X [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 triglyceride (TG) in mmol/L assessed by clinical blood test [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences — Шэньчжэнь

Идентификаторы

NCT: NCT06432491 · KYLLHS-20240201A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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