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Recruiting NCT06432491

The Association Between Core Temperature and Health

No phase Interventional Body Temperature Changes Body Composition Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drinking cold water.
Who it may be relevant to
Registry conditions: Body Temperature Changes, Body Composition, Aging. Basic parameters: 50 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study to Explore How Core Temperature Reduction Influence Health

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Value of core body temperature in centigrade assessed by e-Celsius [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 [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 [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 [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.]
  • Body composition- volume of fat mass in cm^3 assessed by uMR 790 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 outcome measures (10)
  • Intensity of physical activity in three types (light, moderate, vigorous) assessed by GT3X [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 [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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences — Shenzhen

Identifiers

NCT: NCT06432491 · KYLLHS-20240201A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗