跳至主要内容
临床试验/NCT05563896
NCT05563896已完成不适用

The Energy Cost of Living in the Developing World

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2023年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Bioelectrical impedance

研究概览

简要总结

By 2050 there will be 9 billion people on earth. Yet a major issue facing governments is that the current method by which food demands are estimated is widely acknowledged to be completely inaccurate. There is an accurate method available. It is based on measurements of isotope elimination and is called the doubly-labeled water (DLW) method. As part of an initiative sponsored by the International Atomic energy agency (IAEA), the investigators recently compiled a database of measurements using this technique. It showed that use of the DLW method has been mostly restricted to the USA and western Europe. It has been rarely applied across Africa and Asia. There is a clear need to fill this gap in our knowledge providing information that governments across the belt and road countries can use to forecast future food demands. A letter of support from the IAEA confirms the practical importance of having these data which will become reference standards for food intake estimates across the region. Having this information not only fills a very practical need, but also has a strong scientific purpose. The population of earth is not only getting bigger, but the people are getting fatter. The causes of this obesity epidemic are strongly disputed with some suggesting it is due to our increasingly sedentary lives (computers, cars, phones etc), but others suggesting it is mostly due to changing food patterns (junk food and sugar sweetened beverages). Measuring energy expenditure of people across countries that vary enormously in their levels of obesity will address whether falling expenditure due to lowered physical activity is a key cause of the epidemic.

详细描述

Energy Expenditure and Activity

Energy expenditure, body composition, and metabolism will be assessed by the following measures:

Total Energy Expenditure (TEE) using Doubly-labeled water (DLW):

TEE will be measured using the DLW method. Urine samples from all participants in the DLW subset will be stored at -20 oC and shipped on dry ice for analysis in the laboratory of Dr. John Speakman at the University of Aberdeen, or the Shenzhen Institute of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation. TEE will then be calculated using mean CO2 production.

Resting Metabolic Rate (RMR):

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adults working at least 3 out of 7 days per week for a total of >12 hours per week
  • ages 18-50 years
  • willing to enroll in the study and complete all study requirements

排除标准

  • current pregnancy or pregnancy within the last 12 months, and/or currently breast feeding or lactating
  • Individuals with known non-communicable disease notably diabetes, cardiovascular disease or cancer
  • any diseases or chronic use of medications that would influence ability to comply with the study requirements
  • Individuals with infectious disease will also be excluded (HIV, Lassa fever, malaria and Sars-Cov2) In sites where large populations adhere to Ramadan, we will avoid religious festival periods.

结局指标

主要结局

Bioelectrical impedance

时间窗: 10 minutes

The BIA method will be used to estimate total body water, fat and fat free mass using the BIA machine available at each site. Since this is a cross-sectional study, a uniform BIA machine is not specified as a requirement in the protocol. Where available body composition by DZ=XA will also be measured.

Resting Metabolic Rate (RMR)

时间窗: 40 minutes

RMR will be measured by indirect calorimetry while participants are resting supine in thermoneutral conditions. Oxygen consumption and CO2 production will be measured over a period of 25 min, and measurements from the final 10 min will be used to calculate RMR using Weir's equation. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements.

Total Energy Expenditure (TEE)

时间窗: 14 days

TEE will be measured using the DLW method. Urine samples from all participants in the DLW subset will be stored at -20 oC and shipped on dry ice for analysis in the laboratory of Dr. John Speakman at the University of Aberdeen, or the Shenzhen Institute of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation. TEE will then be calculated using mean CO2 production.

Physical Activity

时间窗: 14 days

Physical activity estimates obtained from the activity monitors will be used to assess energy expenditure concurrently with TEE and RMR measurements. The output generated from the accelerometer worn near the hip will include the following: 24-hour physical activity and sleep/wake measurements including acceleration, activity counts, energy expenditure, and physical activity intensity

Height, Weight, Waist Circumference, and Blood Pressure

时间窗: 20 minutes

Duplicate measurements of weight (to +0.1kg), height (to +0.1 cm), hip and waist circumference (to +0.3 cm), and blood pressure will be taken. At visit 1, fasting weight will be measured at the beginning of the visit. Fasting weight will be measured at visit 2 and, if applicable.

Environmental temperature

时间窗: 14 days

The Ibutton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment. The iButtons can be affixed to the hand bag (or clothes) to measure the subject exposure temperature, an indoor wall of home and workplace, and the building outside to measure the outdoor temperature using a strip of adhesive, water resistant, medical grade tape.

次要结局

  • Microbiomics(1 month)
  • Metabolomics(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John R. Speakman

Principal Investigator

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

研究点 (1)

Loading locations...

相似试验

The Energy Cost of Living in the Developing World | 临床试验