- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563896
The Energy Cost of Living in the Developing World
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518055
- Shenzhen Institute of Advanced Technology,Chinese Academy of Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: John R. Speakman, Doctor, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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