The Energy Cost of Living in the Developing World

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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):

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.

Physical Activity:

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.

Body Composition

Bioelectrical impedance (BIA):

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.

Height, Weight, Waist Circumference, and Blood Pressure:

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:

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 handbag (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.

Metabolomics and SNP genotyping:

The subjects will have their venous blood collected in a fasted state. 4ml of venous blood (BD vacutainer K2 EDTA, BD, USA) will be used to separate plasma for metabolomics analysis and to extract genomic DNA (TIANamp Blood DNA kit, TIANGEN, China. QIAamp Midi Blood DNA kit, QIAGEN, Germany) for Single nucleotide polymorphism (SNP) genotyping (Agena MassARRAY, CapitalBio Technology, China).

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Shenzhen, Guangdong, China, 518055
        • Shenzhen Institute of Advanced Technology,Chinese Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

200 healthy adults will be enrolled in this study at five different international sites (China, Iran, Kenya, Senegal, UAE). Forty subjects will be enrolled at each site. In each site, 20 males and 20 females will be recruited respectively. The samples will comprise individuals aged 18-50. Half will be male and half female. Half of the samples will be collected in 'summer' and half in 'winter'. The same individuals will not be measured in both seasons. Once enrollment goals for the subsets have been reached, incoming participants will no longer be offered the opportunity to participate in the project.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
China
We plan to enroll 200 healthy adults in this study at five different international sites (China, Iran, Kenya, Senegal, UAE). Forty subjects will be enrolled at each site. Previous studies showed energy requirements varied with sex and age of the participants. Therefore, in each site, 20 males and 20 females will be recruited respectively. The samples will comprise individuals aged 18-50. Half will be male and half female. Half of the samples will be collected in 'summer' (June, July and August) and half in 'winter' (October, November and December). The same individuals will not be measured in both seasons.
No intervention
Sénégal
Forty subjects will be enrolled at Senegal site.In Senegal site, 20 males and 20 females will be recruited respectively. The samples will comprise individuals aged 18-50. Half will be male and half female. Half of the samples will be collected in 'summer' (June, July and August) and half in 'winter' (October, November and December). The same individuals will not be measured in both seasons.
No intervention
Kenya
Forty subjects will be enrolled at Kenya site.In Kenya site, 20 males and 20 females will be recruited respectively. The samples will comprise individuals aged 18-50. Half will be male and half female. Half of the samples will be collected in 'summer' (June, July and August) and half in 'winter' (October, November and December). The same individuals will not be measured in both seasons.
No intervention
Iran
Forty subjects will be enrolled at Iran site.In Iran site, 20 males and 20 females will be recruited respectively. The samples will comprise individuals aged 18-50. Half will be male and half female. Half of the samples will be collected in 'summer' (June, July and August) and half in 'winter' (October, November and December). The same individuals will not be measured in both seasons.
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Energy Expenditure (TEE)
Time Frame: 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.
14 days
Resting Metabolic Rate (RMR)
Time Frame: 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.
40 minutes
Physical Activity
Time Frame: 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
14 days
Bioelectrical impedance
Time Frame: 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.
10 minutes
Height, Weight, Waist Circumference, and Blood Pressure
Time Frame: 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.
20 minutes
Environmental temperature
Time Frame: 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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolomics
Time Frame: 1 month
The subjects will have their venous blood collected in a fasted state. 4ml of venous blood (BD vacutainer K2 EDTA, BD, USA) will be used to separate serum for metabolomics analysis. The subjects will have their faecal samples collected by penkit and extract the microbial DNA for Microbiomics analysis. Serum microbiome DNA samples will be shipped to Japan to get metabolomics analysed.
1 month
Microbiomics
Time Frame: 1 month
The subjects will have their faecal samples collected by penkit and extract the microbial DNA for Microbiomics analysis. Faecal microbiome DNA samples will be shipped to Japan to get Microbiomics analysed.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John R. Speakman, Doctor, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SIAT-IRB-220715-H0604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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