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Nutrition, HealthyNCT07054294

Total Energy Expenditure Across the Life Course in Low-and Middle-Income Countries -- Chinese Children

An observational study of Nutrition, Healthy, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

By 2050, there will be 9 billion people on earth. It will be necessary to feed them to avoid the population catastrophe predicted by Malthus 150 years ago. Yet a major issue facing governments is that the current method by which food demands are estimated is widely acknowledged as completely inaccurate. Read more about this study

Who is it for?
Ages 7 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Nutrition, Healthy
How many people
70 participants
Where
1 siteChina
Study dates
15 Sep 2025to 30 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: The study population will consist of healthy children aged 7 to 13 years who exhibit normal growth and development. Participants will neither be overweight nor obese, nor will they have any nutritional deficiencies. They will be capable of cooperating to complete all required measurements. None of the children will have been diagnosed with chronic diseases or musculoskeletal injuries or disabilities. Additionally, all participants will be free from acute clinical illnesses for at least seven days prior to the study.

Who may be able to join

  • -Healthy participants

Who cannot join

  • Malnutrient as defined by the Chinese national standards WS/T 456-2014 and WS/T 586-2018
  • Nutritional deficiencies
  • Overweight
  • Obesity
  • Acute illness within the past 7 days
  • Fever
Show all 20Show fewer
  • Diarrhea
  • Vomiting
  • Chronic diseases
  • Cardiovascular diseases
  • Diabetes mellitus or any form of metabolic disorders
  • Type 1 or Type 2 diabetes
  • Metabolic syndrome
  • Hyperlipidemia
  • Dyslipidemia
  • Renal diseases
  • Chronic kidney disease
  • Nephrotic syndrome
  • Musculoskeletal injuries
  • Disabilities

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xueying Zhang, Doctor contact

18201296155

zhangxy@siat.ac.cn

Xinyue Ma, Master contact

19966463830

xy.ma5@siat.ac.cn

China1 site, 1 recruiting
  • Shenzhen Institutes of Advanced Technology,Chinese Academy of Sciences

    Shenzhen, Guangdonng, 518055

    Recruiting

Other trials in China

About this study

Official title: Study on Total Energy Expenditure and Its Influencing Factors in Chinese Children Aged 7-13 Years (Including Rural Areas) Using the Doubly Labelled Water Method

By 2050, there will be 9 billion people on earth. It will be necessary to feed them to avoid the population catastrophe predicted by Malthus 150 years ago. Yet a major issue facing governments is that the current method by which food demands are estimated is widely acknowledged as completely inaccurate. An accurate method is available. It is based on measurements of isotope elimination, called the doubly labelled water (DLW) method. In 2018, the International Atomic Energy Agency (IAEA) hosted and compiled a database of measurements using this technique. It showed that the use of the DLW method has been mostly restricted to the USA and Western Europe. It has rarely been applied across Africa and Asia. The database also focused on adults, leaving much unknown about the energy balance in children and adolescents. There is a clear need to fill this gap in knowledge, providing information that governments across Low- and Middle-Income countries can use to forecast future food demands. In China, the prevalence of overweight and obesity among children and adolescents is increasing. In 2009, 22.1% of Chinese youth aged 7-17 years were either overweight or obese, according to the China Health and Nutrition Survey. The obesity rate has increased fourfold since 1995. One of the most concerning problems is the persistence of childhood obesity into adulthood. The causes of this obesity epidemic are strongly disputed, with some suggesting it is due to increasingly sedentary lifestyles (computers, cars, phones, etc.), while others suggest it is mostly due to changing food patterns (junk food and sugar-sweetened beverages). Measuring energy expenditure in children and adolescents in China will address whether declining expenditure due to reduced physical activity is a key cause of the epidemic. Most measurements come from urban populations, leaving rural populations greatly underrepresented.

Read the detailed description

The investigators will recruit healthy Chinese children aged 7-13 years to participate in a study investigating growth and energy needs. Each participant will complete basic anthropometric measurements-including height, weight, waist and hip circumference, and mid-upper arm circumference. Questionnaires will be used to assess family socioeconomic status, dietary intake, and pubertal development. The investigators will also measure total energy expenditure, basal metabolic rate, physical activity, body composition, and environmental temperature exposure.

This research will provide accurate data on the energy expenditure of children and adolescents living in China. These data will inform national estimates of food and energy requirements, support public health nutrition strategies, and help fill critical data gaps in the IAEA Doubly Labeled Water (DLW) database.

Study Details Anthropometric Measurements

  1. Height: Height will be measured using a Seca 217 stadiometer. Participants will stand barefoot with feet approximately 60° apart. Heels, sacrum, and shoulder blades will be placed against the stadiometer's vertical rod. The head will be aligned so that the upper margin of the ear canal is level with the lower margin of the eye socket. The horizontal plate will be lowered gently to rest on the crown of the head. Two measurements will be taken and averaged; values will be recorded to the nearest 0.1 cm.
  2. Body Weight: After an overnight fast, body weight will be measured in the morning using a calibrated TANITA MC-780 scale. Participants will wear light clothing and no shoes.
  3. Waist Circumference: Waist circumference will be measured at the midpoint between the iliac crest and the lower edge of the 12th rib. Participants will stand with feet 25-30 cm apart and body weight evenly distributed. A flexible tape will be wrapped snugly (without compression), and two measurements will be averaged to the nearest 0.1 cm.
  4. Hip Circumference: Hip circumference will be measured with the participant standing straight, legs together, arms relaxed. The tape will be placed horizontally at the level of the pubic symphysis and the most prominent part of the buttocks. Two measurements will be taken and averaged.
  5. Mid-Upper Arm Circumference: The participant will stand or sit upright with the arm relaxed. The midpoint between the acromion (shoulder) and olecranon (elbow) will be marked. A measuring tape will be wrapped around this midpoint with light contact. Two measurements will be taken and averaged.

Questionnaires

  1. Family Socioeconomic Status: Will be assessed using a structured SES questionnaire.
  2. Pubertal Development: Will be assessed via Tanner staging for secondary sexual characteristics.
  3. Dietary Intake: Will be assessed using three 24-hour dietary recall questionnaires administered on non-consecutive days.

Body Composition (BIA) Bioelectrical impedance analysis (TANITA MC-780) will be used to measure segmental weight (arms, legs, trunk), total body fat percentage (fat%), fat mass (FM), fat-free mass (FFM), total body water (TBW), muscle mass, and BMI.

Basal Metabolic Rate Basal metabolic rate (BMR) will be measured using indirect calorimetry via a Cosmed Quark system with a ventilated hood. After a 10-hour overnight fast and no strenuous activity in the preceding day, participants will lie supine under the hood for 30 minutes. Oxygen consumption and carbon dioxide production will be monitored, and the final 10 minutes will be used to calculate BMR (Weir, 1949). Equipment will be validated monthly via alcohol burn tests and turbine flow calibration.

Total Energy Expenditure (DLW Method) Total energy expenditure (TEE) will be measured using the doubly labeled water (DLW) method. Urine samples will be collected and stored at -20 °C, then shipped on dry ice to Dr. John Speakman's laboratory at the University of Aberdeen or to the Shenzhen Institute of Advanced Technology. Isotope ratios will be analyzed using a near-infrared isotope gas analyzer. Mean CO₂ production will be calculated using equations developed by Speakman et al. (2021), and TEE will be derived using the Weir equation (1949).

Environmental Temperature Exposure Environmental exposure will be monitored using iButton sensors (DS1921G). These will be placed in the participant's living environment (e.g., on a backpack, clothing, indoor wall, or building exterior) using waterproof medical-grade adhesive. This will allow measurement of ambient temperature during the study period.

Physical Activity Physical activity will be monitored using ActiGraph GT3X accelerometers worn at the waist for 14 consecutive days, except during water activities (e.g., bathing or swimming). Data will be considered valid if the monitor is worn for at least 12 hours on four days, including at least two weekdays and two weekend days. The first day of wear and any day with insufficient data will be excluded from analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Height

    Height in centimetres will be measured by Leicester stadiometer(Seca 217, Germany).

    Measured: About 3 minutes.

  2. Weight

    Weight in kilograms will be measured by TANITA.

    Measured: About 5 minutes.

  3. BMI

    BMI values in kg/m2 were calculated from weight measured by TANITA and height measured by Leicester stadiometer (Seca 217, Germany).

    Measured: About 10 minutes (calculated).

  4. Fat mass

    Fat mass in kilograms will be measured by TANITA.

    Measured: About 3 minutes.

  5. Fat percentage

    Fat percentage will be measured by TANITA.

    Measured: About 3 minutes.

  6. Fat-free mass

    Fat-free mass in kilograms will be measured by TANITA.

    Measured: About 3 minutes.

  7. Muscle mass

    Muscle mass in kilograms will be measured by TANITA.

    Measured: About 3 minutes.

  8. Total body water

    Total body water in kilograms will be measured by TANITA.

    Measured: About 3 minutes.

  9. Anthropometric measurements

    Anthropometric measurements, including waist circumference (measured in centimeters), will be obtained using a flexible tape measure following standardized protocols.

    Measured: About 10 minutes.

  10. Anthropometric measurements

    Anthropometric measurements, including hip circumference (measured in centimeters), will be obtained using a flexible tape measure following standardized protocols.

    Measured: About 10 minutes.

  11. Anthropometric measurements

    Anthropometric measurements, including mid-upper arm circumference (measured in centimeters), will be obtained using a flexible tape measure following standardized protocols.

    Measured: About 10 minutes.

  12. Family socioeconomic status

    Family socioeconomic status will be assessed by the Family Socioeconomic Status Questionnaire (SES).

    Measured: About 5 minutes.

  13. Secondary sexual characteristics

    The Tanner stages are used to assess the development of secondary sexual characteristics and are divided into five stages. For boys, the evaluation includes pubic hair development and genital development (including testicular and penile growth). For girls, the evaluation includes pubic hair development and breast development (thelarche).

    Measured: About 5 minutes.

  14. Dietary intake

    The 24-hour dietary recall questionnaire is used to investigate the dietray intake level of the subjects. Three daily meals will be collected to calculate the dietary intake in kcal or MJ.

    Measured: About 10 minutes (three times).

  15. Basal metabolic rate

    The basal metabolic rate in kcal or MJ will be measured by respiratory indirect calorimetry (Cosmed).

    Measured: About 30 minutes.

  16. Total energy expenditure

    Total energy expenditure in kcal or MJ will be measured using the DLW method. TEE will then be calculated using mean CO2 production using the Weir equation.

    Measured: About 14 days.

  17. Environmental temperature

    The iButton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment, measured in degrees Celsius (°C).

    Measured: About 14 days.

  18. Physical activity

    Physical activity of the participants will be recorded using a GT3X accelerometer worn at the waist for a consecutive period of 14 days. Outcomes measured by the GT3X included physical activity energy expenditure in kcal or MJ, Total MVPA in minutes per day , and Vector Magnitude Counts expressed as counts per minute.

    Measured: About 14 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054294
Sponsor's protocol ID
SIAT-IRB-241115-H0927
Status last verified
Jun 2025
First submitted
17 Jun 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33665639
  • 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.

    PubMed 15394301

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition, Healthy, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xueying Zhang, Doctor (18201296155, zhangxy@siat.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Height (time frame: About 3 minutes.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07054294, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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