NCT05563896

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

September 25, 2022

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Total Energy Expenditure (TEE)

    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)

    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

    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

    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

    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

    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 Outcomes (2)

  • Metabolomics

    1 month

  • Microbiomics

    1 month

Study Arms (4)

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.

Other: 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.

Other: 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.

Other: 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.

Other: No intervention

Interventions

No intervention

ChinaIranKenyaSénégal

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institute of Advanced Technology,Chinese Academy of Sciences

Shenzhen, Guangdong, 518055, China

Location

Related Publications (2)

  • Speakman JR, Yamada Y, Sagayama H, Berman ESF, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Creasy SA, Das SK, Cooper R, Dugas LR, Ebbeling CB, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Ludwig DS, Martin CK, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl CU, Melanson EL, Luke AH, Pontzer H, Rood J, Schoeller DA, Westerterp KR, Wong WW; IAEA DLW database group. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med. 2021 Feb 16;2(2):100203. doi: 10.1016/j.xcrm.2021.100203. eCollection 2021 Feb 16.

    PMID: 33665639BACKGROUND
  • WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.

    PMID: 15394301BACKGROUND

Study Officials

  • John R. Speakman, Doctor

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2022

First Posted

October 3, 2022

Study Start

April 28, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations