Total Energy Expenditure in Healthy Chinese Populations: A Nationwide Study Using the Doubly Labelled Water Method

NCT ID: NCT07178054

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-01

Brief Summary

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Between 1990 and 2022, the global prevalence of obesity more than doubled, representing a critical public health concern. China has mirrored this trend, with rapidly increasing rates of overweight and obesity across all age groups. According to the 'Report on Chinese Residents' Nutrition and Chronic Diseases (2020)', 50.7% of Chinese adults are now classified as overweight or obese. Among children and adolescents aged 6 to 17 years, data from the 'Atlas of Nutrition and Health Status of Chinese Children' indicates that the prevalence of overweight and obesity has reached 26.5%.

Obesity is associated with a broad spectrum of adverse health outcomes across the life course. In children, excess adiposity negatively affects skeletal maturation, neurocognitive development, and psychosocial well-being, while also increasing the likelihood of obesity and metabolic dysfunction in adulthood. In adults, obesity is a major risk factor for a range of non-communicable diseases (NCDs), including type 2 diabetes mellitus, hypertension, cardiovascular disease, non-alcoholic fatty liver disease, osteoarthritis, certain cancers, and all-cause premature mortality. Beyond its health implications, obesity imposes substantial economic and social burdens, including increased healthcare expenditure and reduced workforce productivity.

The etiology of the obesity epidemic is multifactorial and remains under active investigation. Hypotheses center around a chronic imbalance between energy intake and expenditure, driven by behavioral, environmental, and physiological factors. Notably, decreased physical activity associated with sedentary lifestyles and increased consumption of energy-dense, nutrient-poor foods have been implicated as key contributors. However, the relative contributions of reduced energy expenditure versus increased energy intake remain insufficiently quantified at the population level. Accurate assessment of total energy expenditure (TEE) is therefore essential to elucidate the energy dynamics underlying the obesity epidemic.

Current approaches for estimating population-level energy and food requirements are often based on indirect methods with limited precision. The doubly labelled water (DLW) technique, which quantifies TEE through measurement of isotope elimination rates (\^2H and \^18O), remains the gold standard for assessing free-living energy expenditure. However, its application has been predominantly confined to high-income countries with well-established research infrastructure. In contrast, the use of DLW in low- and middle-income countries-including China-remains minimal, resulting in critical data gaps that hinder the development of context-specific dietary recommendations and energy requirement models.

To address these limitations, this study will apply the DLW method to measure TEE in healthy children and adults in China. In parallel, the study will assess key modulators of energy metabolism, including anthropometric and physiological parameters, gut microbiota composition, habitual physical activity, and ambient temperature exposure. The resulting dataset will provide high-resolution, population-specific evidence to inform national dietary reference intakes and support the formulation of evidence-based public health strategies aimed at obesity prevention and metabolic health promotion.

Detailed Description

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The investigators will recruit healthy children aged 7 to 18 and healthy adults aged 30 to 60 from within the country to participate in a study to explore their energy requirements and factors.

The following measurements will be conducted in both children and adults:

1. 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. Thigh Circumference: Thigh circumference will be measured with the participant standing straight, legs together, arms relaxed. The tape measure should be wrapped horizontally around the thickest part of the thigh (usually about 10 centimeters below the hip crease), closely adhering to the skin but not pressing on the soft tissue. The average of two measurements will be taken, accurate to 0.1 cm.
6. Neck Circumference: Neck circumference will be measured with the participant keeping their head straight and drooping their shoulders naturally. The tape measure should be placed horizontally at the lower edge of the thyroid cartilage (Adam's apple) in front of the neck, passing through the lower part of the bilateral occipital protuberances on both sides. The measurement should be taken twice and the average value will be obtained, accurate to 0.1 cm.
7. Blood Pressure: Blood pressure will be measured with the participant relaxing shoulders, straightening backs, sitting upright and placing arms flat on the table at the same level as the heart. Participants will rest quietly for more than 5-10 minutes before measuring blood pressure. The blood pressure cuff will tie at a distance of one finger above the elbow, with the center point level with the heart. Record the blood pressure at the end.
8. Heart Rate: Heart rate will be measured with the participant relaxing shoulders, straightening backs, sitting upright and placing arms flat on the table at the same level as the heart. Participants will rest quietly for more than 5-10 minutes before measuring blood pressure. The blood pressure cuff will tie at a distance of one finger above the elbow, with the center point level with the heart. Record the heart rate at the end.
9. Abdominal Fat: Abdominal fat will be measured with the participant lying on their back and exposing abdomen as instructed by the doctor. Trained personnel will use the DW-360 to measure participants' abdominal fat.
10. Bone Mineral Density: Bone mineral density will be measured with the participant lying flat on their back and remaining still as instructed by the technician. Professional personnel will use the Dual Energy X-ray (DXA) scanner to measure participants' bone mineral density.
2. Blood biochemistry test and gut microbiota detection

1. Blood Index: Blood index will be measured by taking blood samples from participants after a 10-hour fast, including red blood cell (RBC), white blood cells (WBC), hemoglobin (HB), etc.
2. Lipid Profile: Lipid profile will be measured by taking blood samples from participants after a 10-hour fast, including total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C).
3. Liver Function: Liver function will be measured by taking blood samples from participants after a 10-hour fast, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), direct bilirubin (DB) and indirect bilirubin (IB), etc.
4. Renal Function: Renal function will be measured by taking blood samples from participants after a 10-hour fast, including blood urea nitrogen (BUN), serum uric acid (SUA) and serum creatinine (SCr).
5. Vitamin D levels: Vitamin D levels will be measured by taking blood samples from non-fasting participants.
6. Gut Microbiota: Gut microbiota is obtained by collecting fecal samples from participants.
3. Questionnaires

1. Comprehensive questionnaire for adults: Will be conducted through a set of questionnaires covering demographic information, past health conditions, dietary structure, and sleep quality.
2. Pubertal development for children under guardianship: Will be assessed via Tanner staging for secondary sexual characteristics.
3. Dietary intake for participants: Will be assessed using three 24-hour dietary recall questionnaires administered on non-consecutive days.
4. Body composition and energy expenditure

1. Body Composition:

Bioelectrical impedance analysis (TANITA MC-780) and DXA (Hologic, Horizon Wi)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) and muscle mass.
2. Basal Metabolic Rate(BMR) :

Basal metabolic rate 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.
3. Total Energy Expenditure:

Total energy expenditure (TEE) will be measured using the doubly labelled 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).
4. Environmental Temperature Exposure:

Environmental temperature exposure will be monitored using iButton sensors (DS1921G). These will be placed in the participant's living environment (eg, 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.
5. 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.

The following additional measurements will be performed in children:

1. Mid-Upper Arm Circumference: Mid-upper arm circumference will be measured with the participant standing straight, legs together, arms 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.
2. Grip Strength: Grip strength will be measured by the dynamometer(CAMRY, EH101), Read the displayed number on the dynamometer as the grip strength value. Take the maximum value of the two measurements, accurate to 0.1 kg.
3. Skin Carotenoid: Skin carotenoid will be measured with the participant covering the non-index finger on the veggie meter. The non-index finger will clean with alcohol to ensure they were free of oil and fat before measuring. Then, the content of carotenoids in the participant's skin will be accurately evaluated.

This study will provide accurate data on the energy consumption of healthy people living in China. These data will serve as a basis for estimating the country's food and energy requirements, support public health nutrition strategies, and help fill the key data gaps in the domestic DLW database.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Healthy participants

Exclusion Criteria

1. Malnutrient as defined by the Chinese national standards WS/T456-2014 and WS/T 586-2018

1. Nutritional deficiencies
2. Overweight
3. Obesity
2. Acute illness within the past 7 days

1. Fever
2. Diarrhea
3. Vomiting
3. Chronic diseases

1. Cardiovascular diseases
2. Diabetes mellitus or any form of metabolic disorders

* Type 1 or Type 2 diabetes
* Metabolic syndrome
* Hyperlipidemia
* Dyslipidemia
3. Renal diseases

* Chronic kidney disease
* Nephrotic syndrome
4. Musculoskeletal injuries
5. Disabilities
Minimum Eligible Age

7 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Xueying Zhang

Associate researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xueying Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Locations

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

Shenzhen Institutes of Advanced Technology,Chinese Academy of Sciences

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status NOT_YET_RECRUITING

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Qingdao Center Hospital of Rehabilitation University

Qingdao, Shandong, China

Site Status NOT_YET_RECRUITING

Tacheng Prefecture People's Hospital

Tacheng, Xinjiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xueying Zhang, Doctor

Role: CONTACT

18201296155

Jiangyan Deng, Master

Role: CONTACT

17381368352

Facility Contacts

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Jiangyan Deng, Master

Role: primary

17381368352

John Speakman, Doctor

Role: primary

15810868669

Xueying Zhang, Doctor

Role: backup

18201296155

Jiangyan Deng, Master

Role: primary

17381368352

Jiangyan Deng, Master

Role: primary

17381368352

Jiangyan Deng, Master

Role: primary

17381368352

Jiangyan Deng, Master

Role: primary

17381368352

Jiangyan Deng, Master

Role: primary

17381368352

References

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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.

Reference Type BACKGROUND
PMID: 33665639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15394301 (View on PubMed)

Other Identifiers

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SIAT-IRB-250815-H1005

Identifier Type: -

Identifier Source: org_study_id

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