Energy MetabolismNCT07056504
Technologies and Systems for Assessing Human Energy Metabolism and Nutritional Rehabilitation
An observational study of Energy Metabolism and Nutrition, Healthy, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
The objective of this observational study is to integrate the doubly labeled water (DLW) database from healthy individuals with multimodal data-including, but not limited to, weight, height, age, sex, race, elevation-from cohorts undergoing rehabilitation following movement impairments or neurological injuries. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Energy Metabolism, Nutrition, Healthy
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2025to 31 Dec 2025
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals aged 20 to 70 years, both male and female, who are recovering from stroke or motor injuries are eligible for this study; however, those with the following conditions are not permitted to participate: pregnancy, pre-pregnancy period, lactation, loss of consciousness or mobility, severe metabolic diseases (such as diabetes, other hereditary metabolic disorders, etc.), psychogenic anorexia, uremia, and inability to lie flat for one hour. Additionally, individuals with contraindications for magnetic resonance imaging (MRI) are excluded from this trial; these include a history of pacemaker implantation, presence of metallic implants in the body, and claustrophobia. This criterion ensures that all participants meet the necessary health and safety requirements for the study.
Who may be able to join
- Male and female participants aged 20 to 70 years old;
- Rehabilitation patients with stroke or motor injuries;
Who cannot join
- Loss of autonomous mobility;
- Loss of consciousness;
- Individuals with metallic implants (e.g., pacemakers);
- Severe metabolic diseases (e.g., diabetes, other hereditary metabolic disorders);
- Patients with claustrophobia;
- Individuals with anorexia nervosa;
Show all 9Show fewer
- Women in the preconception period, pregnancy, or lactation;
- Uremic patients;
- Inability to lie flat for one hour.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Jianxiang Hospital Group
Foshan, Guangdong, 528012
Tianyi Wang, Master, 15367493350, wangtianyi@cmu.edu.cn
About this study
Official title: Active Rehabilitation Training System for Motor and Cognitive Function Technologies and Systems for Assessing Human Energy Metabolism and Nutritional Rehabilitation
The objective of this observational study is to integrate the doubly labeled water (DLW) database from healthy individuals with multimodal data-including, but not limited to, weight, height, age, sex, race, elevation-from cohorts undergoing rehabilitation following movement impairments or neurological injuries. Machine learning algorithms will be used to develop injury-specific predictive models of energy requirements.
The primary research question is:
How does energy metabolism change during the rehabilitation process in individuals recovering from traumatic brain injury, stroke, or major surgical procedures? To answer this, participants will undergo a comprehensive set of assessments, including measurements of height and weight, body composition, resting metabolic rate, physical activity levels, total energy expenditure, psychological health, food intake and hunger ratings, sleep quality, cognitive performance, non-invasive brain function monitoring, and gait analysis. Fecal and blood samples will also be collected for untargeted metabolomics analysis.
Read the detailed description
- Body Weight and Height Participants will fast overnight prior to measurement. Body weight will be measured in the morning using a calibrated Seca digital scale, with participants wearing light clothing and no shoes. Height will be measured using a Seca 217 stadiometer, with participants standing barefoot.
- Resting Energy Expenditure (REE) REE will be measured via indirect calorimetry using a respiratory hood system (Cosmed). Participants will report to the laboratory after an overnight fast, lie supine on a flat bed, and have the hood placed over their head. Oxygen consumption and carbon dioxide production will be recorded for 40 minutes, with the final 10 minutes used for analysis. The system will be quality-checked regularly using a turbine test, and monthly validation will be conducted via an alcohol combustion test.
- Total Energy Expenditure (TEE) TEE will be assessed using two complementary methods: Doubly Labeled Water (DLW) Method: Urine samples from the DLW subset will be stored at -20 °C and shipped on dry ice to Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences. Isotope ratios will be analyzed using a Liquid Water Isotope Analyzer (ABB). CO₂ production will be calculated using the latest equation from Speakman et al. (2021, Cell Reports Medicine), and TEE will be estimated using the Weir equation. Metabolic Chamber: TEE will also be measured using a whole-body metabolic chamber (Maastricht Instruments, Netherlands), which continuously tracks oxygen consumption and carbon dioxide production. Participants will remain in the chamber for 48 hours, engaging in routine daily activities. Data from the second day will be analyzed to estimate TEE.
- Physical Activity Physical activity will be assessed using a GT3X accelerometer worn on the hip for 15 consecutive days. The device should not be worn during bathing or swimming. Data from the first day and any day with <12 hours of wear time will be excluded. A valid dataset requires at least two weekdays and two weekend days of usable data.
- Body Composition Body composition will be measured using the following techniques: Magnetic Resonance Imaging (MRI; Philips Multiva 1.5T) Dual-energy X-ray Absorptiometry (DXA; HOLOGIC Horizon Wi, USA) Bioelectrical Impedance Analysis (BIA; TANITA MC-980, Japan) Parameters to be assessed include total and regional fat mass, lean mass, and fat percentage across the limbs and trunk. MRI will be used for whole-body fat distribution analysis by trained technicians.
- Mental Health Assessment The Symptom Checklist-90 (SCL-90) will be used to evaluate psychological well-being. This tool measures ten dimensions: somatization, obsessive-compulsive traits, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoid ideation, psychosis, and additional symptoms. Scores for each dimension and overall symptom severity will be calculated.
- Food Intake and Hunger Assessment Meals will be designed based on the energy distribution guidelines from the Chinese Dietary Guidelines. After a standardized lunch, participants will receive a test meal (packaging removed) containing predefined macronutrient and energy levels five hours later. Food intake will be ad libitum, and hunger levels will be assessed based on behavioral indicators. Blood samples (4 mL) will be collected at baseline (pre-dinner), and 15, 30, and 60 minutes post-dinner for appetite-related hormones analysis such as ghrelin and PYY.
- Sleep Quality Monitoring Sleep will be monitored using the Heartcare Youhu Pro AI Precision Health Management System, which tracks total sleep duration, sleep efficiency, cycle durations, heart rate, and respiratory patterns. These metrics will be used to assess sleep quality.
- Cognitive Function Assessment Cognitive performance will be evaluated using: Mini-Mental State Examination (MMSE): Assesses orientation, memory, attention, language, and visuospatial function. Scores of 25-30 indicate normal function; 20-24 mild, 10-19 moderate, and <10 severe cognitive impairment. Montreal Cognitive Assessment (MoCA): Screens for impairment across eight cognitive domains. A score ≥26 is considered normal.
- Non-Invasive Brain Function Monitoring Functional Near-Infrared Spectroscopy (fNIRS) will be used to assess brain activity by measuring changes in oxyhemoglobin and deoxyhemoglobin concentrations. We may use the BS2000 near-infrared imaging system for this purpose. Assessment Areas: Prefrontal cortex, motor cortex, frontal pole, dorsolateral prefrontal cortex, primary motor/somatosensory cortex, premotor and supplementary motor cortex-on both healthy and affected sides. Key Indicators:HbO, HbR, and HbT concentration changes during a 0-40 sec task window. 3D topological maps (HbO beta values). Activation levels at rest. Functional connectivity (HbO).
- Gait Analysis Laboratory A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for gait analysis. This non-invasive system captures: Spatiotemporal Parameters: Step time, frequency, speed, stride length/width, and symmetry Kinematic Parameters: Joint angles (pelvis, hip, knee), motion curves, ground reaction forces, and joint torques
- Gut Microbiota and Blood Metabolomics Mid-portion fecal samples and 5 mL blood samples will be collected. Fecal samples will undergo non-targeted microbiome analysis at Novogene, while blood samples will be analyzed at Biotree Bioscience for metabolomic profiling, including appetite-related hormones such as ghrelin and PYY.
- Conditions
- Energy Metabolism, Nutrition, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation | Individuals aged 20 to 70 years, who are recovering from stroke or motor injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Measured: Height will be measured on the first day after volunteers are enrolled.
Resting Energy Expenditure (REE)
REE will be measured via indirect calorimetry using a respiratory hood system (Cosmed). Participants will report to the laboratory after an overnight fast, lie supine on a flat bed, and have the hood placed over their head. Oxygen consumption and carbon dioxide production will be recorded for 40 minutes, with the final 10 minutes used for analysis. The system will be quality-checked regularly using a turbine test, and monthly validation will be conducted via an alcohol combustion test.
Measured: The measurement of REE will be completed within fifteen days after the volunteers are enrolled.
Total Energy Expenditure (TEE)
TEE will be assessed using two complementary methods:
Doubly Labeled Water (DLW) Method: Urine samples from the DLW subset will be stored at -20 °C and shipped on dry ice to Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences. Isotope ratios will be analyzed using a Liquid Water Isotope Analyzer (ABB). CO₂ production will be calculated using the latest equation from Speakman et al. (2021, Cell Reports Medicine), and TEE will be estimated using the Weir equation.
Metabolic Chamber: TEE will also be measured using a whole-body metabolic chamber (Maastricht Instruments, Netherlands), which continuously tracks oxygen consumption and carbon dioxide production. Participants will remain in the chamber for 48 hours, engaging in routine daily activities. Data from the second day will be analyzed to estimate TEE.
Measured: The measurement of TEE will be completed within fifteen days after the volunteers are enrolled.
Physical Activity Level
During the measurement period, all participants will be required to wear a three-axis accelerometer (Actigraph GT3XP-BTLE, USA) for 15 days, covering 24 hours a day, including sleep. Participants can remove the accelerometer only when showering, bathing, swimming, or engaging in other water activities. This device will provide multiple parameters of physical activity levels, including raw acceleration data, activity counts, and vector magnitudes. Raw acceleration data captures subtle changes in individual movements, activity counts measure the intensity of physical activity over specific time periods, and vector magnitudes integrate acceleration information from all directions. These three indicators were used to comprehensively evaluate participants' physical activity levels.
Measured: GT3X will be worn by the volunteers on the first day of enrollment and continue for fifteen days.
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Philips Multiva 1.5T ).
Measured: Fat mass will be completed within fifteen days after the volunteers are enrolled.
Mental Health Assessment
The Symptom Checklist-90 (SCL-90) will be used to evaluate psychological well-being. This tool measures ten dimensions: somatization, obsessive-compulsive traits, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoid ideation, psychosis, and additional symptoms. Scores for each dimension and overall symptom severity will be calculated.
Measured: Mental health assessment will be completed within fifteen days after the volunteers are enrolled.
Cognitive Function Assessment
Cognitive performance will be evaluated using:
Mini-Mental State Examination (MMSE): Assesses orientation, memory, attention, language, and visuospatial function. Scores of 25-30 indicate normal function; 20-24 mild, 10-19 moderate, and <10 severe cognitive impairment.
Measured: Cognitive function assessment will be completed within fifteen days after the volunteers are enrolled.
Fat free mass
Fat free mass will be measured by Bioimpedance Analysis (Tanita, Philips Multiva 1.5T).
Measured: Fat free mass will be completed within fifteen days after the volunteers are enrolled.
Body weight
Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes. .
Measured: Body weight will be measured on the first day after volunteers are enrolled.
Cognitive Function Assessment
Cognitive performance will be evaluated using:
Montreal Cognitive Assessment (MoCA): Screens for impairment across eight cognitive domains. A score ≥26 is considered normal.
Measured: Cognitive function assessment will be completed within fifteen days after the volunteers are enrolled.
Bone mass
Bone mass will be measured by DXA (HOLOGIC Horizon Wi，America）
Measured: Bone mass will be completed within fifteen days after the volunteers are enrolled.
Hunger Sensation
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, with its packaging removed, includes preset macro-nutrient and energy levels, allowing participants to determine their intake. Hunger sensation will be assessed using a VAS (Visual Analog Scale) for hunger.
Measured: Hunger sensation assessment will be completed within fifteen days after the volunteers are enrolled.
PYY
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, which has been removed from its packaging, includes preset macronutrient and energy levels, allowing participants to determine their intake. Blood samples are collected at 15,30, and 60 minutes before dinner, after dinner, and again before bedtime, with each sample being 2ml (a total of four times, with a permanent indwelling needle). PYY is detected through these blood samples.
Measured: PYY will be measured within fifteen days after the volunteers are enrolled.
Ghrelin
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, which has been removed from its packaging, includes preset macronutrient and energy levels, allowing participants to determine their intake. Blood samples are collected at 15,30, and 60 minutes before dinner, after dinner, and again before bedtime, with each sample being 2ml (a total of four times, with a permanent indwelling needle). Ghrelin is detected through these blood samples.
Measured: Ghrelin will be measured within fifteen days after the volunteers are enrolled.
Total Sleep Duration
Total sleep duration will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Measured: Total sleep duration will be completed within fifteen days after the volunteers are enrolled.
Sleep Efficiency
Sleep efficiency will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Measured: Sleep efficiency will be completed within fifteen days after the volunteers are enrolled.
Sleep Cycle Durations
Sleep cycle durations will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Measured: Sleep cycle durations will be completed within fifteen days after the volunteers are enrolled.
Heart Rate During Sleep
Heart rate during sleep will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Measured: Heart rate during sleep will be completed within fifteen days after the volunteers are enrolled.
Respiratory Patterns During Sleep
Respiratory patterns during sleep will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Measured: Respiratory patterns during sleep will be completed within fifteen days after the volunteers are enrolled.
Step Time
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step time.
Measured: Step time will be completed within fifteen days after the volunteers are enrolled.
Step Frequency
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step frequency.
Measured: Step frequency will be completed within fifteen days after the volunteers are enrolled.
Step Speed
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step speed.
Measured: Step speed will be completed within fifteen days after the volunteers are enrolled.
Stride Length
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for stride length.
Measured: Stride length will be completed within fifteen days after the volunteers are enrolled.
Bilateral Gait Symmetry
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for bilateral gait symmetry.
Measured: Bilateral gait symmetry will be completed within fifteen days after the volunteers are enrolled.
Pelvic, Hip and Knee Joint Angle Parameters
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for pelvic, hip and knee joint angle parameters.
Measured: Pelvic, hip and knee joint Angle parameters will be completed within fifteen days after the volunteers are enrolled.
Joint Torque
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for joint torque.
Measured: Joint torque will be completed within fifteen days after the volunteers are enrolled.
Non-Targeted Microbiome Detection Of Stool Samples
Non-targeted microbiome studies are a comprehensive and unbiased approach to studying microbial communities. This method uses high-throughput sequencing or mass spectrometry to analyze the genomes (metagenomics) or metabolites (metabolomics) of all microorganisms in a sample, without preconceived targets. Since this study does not have a specific target microorganism, we will collect approximately 10ml of midstream fecal samples from participants for the detection of all microorganisms' genomes (metagenomics) or metabolites (metabolomics).
Measured: The retention of stool samples for non-targeted microbiome detection will be completed within 15 days after the enrollment of volunteers, and the sample analysis will be completed before November 1, 2025.
Non-Invasive Brain Function Monitoring
Functional Near-Infrared Spectroscopy (fNIRS) will be used to assess brain activity by measuring changes in oxyhemoglobin and deoxyhemoglobin concentrations. We may use the BS2000 near-infrared imaging system for this purpose.
Assessment Areas: Prefrontal cortex, motor cortex, frontal pole, dorsolateral prefrontal cortex, primary motor/somatosensory cortex, premotor and supplementary motor cortex-on both healthy and affected sides.
Key Indicators:HbO, HbR, and HbT concentration changes during a 0-40 sec task window. 3D topological maps (HbO beta values). Activation levels at rest. Functional connectivity (HbO).
Measured: Non-invasive brain function monitoring will be completed within fifteen days after the volunteers are enrolled.
Cerebral Oxyhemoglobin Concentration
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured cerebral oxyhemoglobin concentration.
Measured: Cerebral oxyhemoglobin concentrationn will be completed within fifteen days after the volunteers are enrolled.
Cerebral Deoxyhemoglobin Concentration
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured cerebral deoxygenated concentration.
Measured: Cerebral deoxyhemoglobin concentration will be completed within fifteen days after the volunteers are enrolled.
Total Hemoglobin Concentration In Cerebral Vasculature
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured total hemoglobin concentration in cerebral vasculature
Measured: Total hemoglobin concentration in cerebral vasculature will be completed within fifteen days after the volunteers are enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start9 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Energy MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueying Zhang, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Investigators
- Xueying Zhang, PhD, Principal investigator, Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesJohn R Speakman, PhD, Principal investigator, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056504
- Sponsor's protocol ID
- SIAT-IRB-250615-H0986
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 2 Sep 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 33665639WEIR 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Rehabilitation Training System for Motor and Cognitive Function Technologies and Systems for Assessing Human Energy Metabolism and Nutritional Rehabilitation
- ClinicalTrials.gov ID
- NCT07056504
- Acronym / sponsor ID
- SIAT-IRB-250615-H0986
- Conditions
- Energy Metabolism, Nutrition, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this observational study is to integrate the doubly labeled water (DLW) database from healthy individuals with multimodal data-including, but not limited to, weight, height, age, sex, race, elevation-from cohorts undergoing rehabilitation following movement impairments or neurological injuries. Machine learning algorithms will be used to develop injury-specific predictive models of energy requirements.
The primary research question is:
How does energy metabolism change during the rehabilitation process in individuals recovering from traumatic brain injury, stroke, or major surgical procedures? To answer this, participants will undergo a comprehensive set of assessments, including measurements of height and weight, body composition, resting metabolic rate, physical activity levels, total energy expenditure, psychological health, food intake and hunger ratings, sleep quality, cognitive performance, non-invasive brain function monitoring, and gait analysis. Fecal and blood samples will also be collected for untargeted metabolomics analysis.
Detailed description
- Body Weight and Height Participants will fast overnight prior to measurement. Body weight will be measured in the morning using a calibrated Seca digital scale, with participants wearing light clothing and no shoes. Height will be measured using a Seca 217 stadiometer, with participants standing barefoot.
- Resting Energy Expenditure (REE) REE will be measured via indirect calorimetry using a respiratory hood system (Cosmed). Participants will report to the laboratory after an overnight fast, lie supine on a flat bed, and have the hood placed over their head. Oxygen consumption and carbon dioxide production will be recorded for 40 minutes, with the final 10 minutes used for analysis. The system will be quality-checked regularly using a turbine test, and monthly validation will be conducted via an alcohol combustion test.
- Total Energy Expenditure (TEE) TEE will be assessed using two complementary methods: Doubly Labeled Water (DLW) Method: Urine samples from the DLW subset will be stored at -20 °C and shipped on dry ice to Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences. Isotope ratios will be analyzed using a Liquid Water Isotope Analyzer (ABB). CO₂ production will be calculated using the latest equation from Speakman et al. (2021, Cell Reports Medicine), and TEE will be estimated using the Weir equation. Metabolic Chamber: TEE will also be measured using a whole-body metabolic chamber (Maastricht Instruments, Netherlands), which continuously tracks oxygen consumption and carbon dioxide production. Participants will remain in the chamber for 48 hours, engaging in routine daily activities. Data from the second day will be analyzed to estimate TEE.
- Physical Activity Physical activity will be assessed using a GT3X accelerometer worn on the hip for 15 consecutive days. The device should not be worn during bathing or swimming. Data from the first day and any day with <12 hours of wear time will be excluded. A valid dataset requires at least two weekdays and two weekend days of usable data.
- Body Composition Body composition will be measured using the following techniques: Magnetic Resonance Imaging (MRI; Philips Multiva 1.5T) Dual-energy X-ray Absorptiometry (DXA; HOLOGIC Horizon Wi, USA) Bioelectrical Impedance Analysis (BIA; TANITA MC-980, Japan) Parameters to be assessed include total and regional fat mass, lean mass, and fat percentage across the limbs and trunk. MRI will be used for whole-body fat distribution analysis by trained technicians.
- Mental Health Assessment The Symptom Checklist-90 (SCL-90) will be used to evaluate psychological well-being. This tool measures ten dimensions: somatization, obsessive-compulsive traits, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoid ideation, psychosis, and additional symptoms. Scores for each dimension and overall symptom severity will be calculated.
- Food Intake and Hunger Assessment Meals will be designed based on the energy distribution guidelines from the Chinese Dietary Guidelines. After a standardized lunch, participants will receive a test meal (packaging removed) containing predefined macronutrient and energy levels five hours later. Food intake will be ad libitum, and hunger levels will be assessed based on behavioral indicators. Blood samples (4 mL) will be collected at baseline (pre-dinner), and 15, 30, and 60 minutes post-dinner for appetite-related hormones analysis such as ghrelin and PYY.
- Sleep Quality Monitoring Sleep will be monitored using the Heartcare Youhu Pro AI Precision Health Management System, which tracks total sleep duration, sleep efficiency, cycle durations, heart rate, and respiratory patterns. These metrics will be used to assess sleep quality.
- Cognitive Function Assessment Cognitive performance will be evaluated using: Mini-Mental State Examination (MMSE): Assesses orientation, memory, attention, language, and visuospatial function. Scores of 25-30 indicate normal function; 20-24 mild, 10-19 moderate, and <10 severe cognitive impairment. Montreal Cognitive Assessment (MoCA): Screens for impairment across eight cognitive domains. A score ≥26 is considered normal.
- Non-Invasive Brain Function Monitoring Functional Near-Infrared Spectroscopy (fNIRS) will be used to assess brain activity by measuring changes in oxyhemoglobin and deoxyhemoglobin concentrations. We may use the BS2000 near-infrared imaging system for this purpose. Assessment Areas: Prefrontal cortex, motor cortex, frontal pole, dorsolateral prefrontal cortex, primary motor/somatosensory cortex, premotor and supplementary motor cortex-on both healthy and affected sides. Key Indicators:HbO, HbR, and HbT concentration changes during a 0-40 sec task window. 3D topological maps (HbO beta values). Activation levels at rest. Functional connectivity (HbO).
- Gait Analysis Laboratory A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for gait analysis. This non-invasive system captures: Spatiotemporal Parameters: Step time, frequency, speed, stride length/width, and symmetry Kinematic Parameters: Joint angles (pelvis, hip, knee), motion curves, ground reaction forces, and joint torques
- Gut Microbiota and Blood Metabolomics Mid-portion fecal samples and 5 mL blood samples will be collected. Fecal samples will undergo non-targeted microbiome analysis at Novogene, while blood samples will be analyzed at Biotree Bioscience for metabolomic profiling, including appetite-related hormones such as ghrelin and PYY.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rehabilitation | – | –Individuals aged 20 to 70 years, who are recovering from stroke or motor injuries |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 20 to 70 years, both male and female, who are recovering from stroke or motor injuries are eligible for this study; however, those with the following conditions are not permitted to participate: pregnancy, pre-pregnancy period, lactation, loss of consciousness or mobility, severe metabolic diseases (such as diabetes, other hereditary metabolic disorders, etc.), psychogenic anorexia, uremia, and inability to lie flat for one hour. Additionally, individuals with contraindications for magnetic resonance imaging (MRI) are excluded from this trial; these include a history of pacemaker implantation, presence of metallic implants in the body, and claustrophobia. This criterion ensures that all participants meet the necessary health and safety requirements for the study.
Key inclusion criteria (2 listed)
- Male and female participants aged 20 to 70 years old;
- Rehabilitation patients with stroke or motor injuries;
Key exclusion criteria (9 listed)
- Loss of autonomous mobility;
- Loss of consciousness;
- Individuals with metallic implants (e.g., pacemakers);
- Severe metabolic diseases (e.g., diabetes, other hereditary metabolic disorders);
- Patients with claustrophobia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Height
Time frame: Height will be measured on the first day after volunteers are enrolled.
Measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Resting Energy Expenditure (REE)
Time frame: The measurement of REE will be completed within fifteen days after the volunteers are enrolled.
REE will be measured via indirect calorimetry using a respiratory hood system (Cosmed). Participants will report to the laboratory after an overnight fast, lie supine on a flat bed, and have the hood placed over their head. Oxygen consumption and carbon dioxide production will be recorded for 40 minutes, with the final 10 minutes used for analysis. The system will be quality-checked regularly using a turbine test, and monthly validation will be conducted via an alcohol combustion test.
Total Energy Expenditure (TEE)
Time frame: The measurement of TEE will be completed within fifteen days after the volunteers are enrolled.
TEE will be assessed using two complementary methods: Doubly Labeled Water (DLW) Method: Urine samples from the DLW subset will be stored at -20 °C and shipped on dry ice to Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences. Isotope ratios will be analyzed using a Liquid Water Isotope Analyzer (ABB). CO₂ production will be calculated using the latest equation from Speakman et al. (2021, Cell Reports Medicine), and TEE will be estimated using the Weir equation. Metabolic Chamber: TEE will also be measured using a whole-body metabolic chamber (Maastricht Instruments, Netherlands), which continuously tracks oxygen consumption and carbon dioxide production. Participants will remain in the chamber for 48 hours, engaging in routine daily activities. Data from the second day will be analyzed to estimate TEE.
Physical Activity Level
Time frame: GT3X will be worn by the volunteers on the first day of enrollment and continue for fifteen days.
During the measurement period, all participants will be required to wear a three-axis accelerometer (Actigraph GT3XP-BTLE, USA) for 15 days, covering 24 hours a day, including sleep. Participants can remove the accelerometer only when showering, bathing, swimming, or engaging in other water activities. This device will provide multiple parameters of physical activity levels, including raw acceleration data, activity counts, and vector magnitudes. Raw acceleration data captures subtle changes in individual movements, activity counts measure the intensity of physical activity over specific time periods, and vector magnitudes integrate acceleration information from all directions. These three indicators were used to comprehensively evaluate participants' physical activity levels.
Fat mass
Time frame: Fat mass will be completed within fifteen days after the volunteers are enrolled.
Fat mass will be measured by Magnetic Resonance Imaging (Philips Multiva 1.5T ).
Mental Health Assessment
Time frame: Mental health assessment will be completed within fifteen days after the volunteers are enrolled.
The Symptom Checklist-90 (SCL-90) will be used to evaluate psychological well-being. This tool measures ten dimensions: somatization, obsessive-compulsive traits, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoid ideation, psychosis, and additional symptoms. Scores for each dimension and overall symptom severity will be calculated.
Cognitive Function Assessment
Time frame: Cognitive function assessment will be completed within fifteen days after the volunteers are enrolled.
Cognitive performance will be evaluated using: Mini-Mental State Examination (MMSE): Assesses orientation, memory, attention, language, and visuospatial function. Scores of 25-30 indicate normal function; 20-24 mild, 10-19 moderate, and <10 severe cognitive impairment.
Fat free mass
Time frame: Fat free mass will be completed within fifteen days after the volunteers are enrolled.
Fat free mass will be measured by Bioimpedance Analysis (Tanita, Philips Multiva 1.5T).
Body weight
Time frame: Body weight will be measured on the first day after volunteers are enrolled.
Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes. .
Cognitive Function Assessment
Time frame: Cognitive function assessment will be completed within fifteen days after the volunteers are enrolled.
Cognitive performance will be evaluated using: Montreal Cognitive Assessment (MoCA): Screens for impairment across eight cognitive domains. A score ≥26 is considered normal.
Bone mass
Time frame: Bone mass will be completed within fifteen days after the volunteers are enrolled.
Bone mass will be measured by DXA (HOLOGIC Horizon Wi，America）
Hunger Sensation
Time frame: Hunger sensation assessment will be completed within fifteen days after the volunteers are enrolled.
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, with its packaging removed, includes preset macro-nutrient and energy levels, allowing participants to determine their intake. Hunger sensation will be assessed using a VAS (Visual Analog Scale) for hunger.
PYY
Time frame: PYY will be measured within fifteen days after the volunteers are enrolled.
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, which has been removed from its packaging, includes preset macronutrient and energy levels, allowing participants to determine their intake. Blood samples are collected at 15,30, and 60 minutes before dinner, after dinner, and again before bedtime, with each sample being 2ml (a total of four times, with a permanent indwelling needle). PYY is detected through these blood samples.
Ghrelin
Time frame: Ghrelin will be measured within fifteen days after the volunteers are enrolled.
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, which has been removed from its packaging, includes preset macronutrient and energy levels, allowing participants to determine their intake. Blood samples are collected at 15,30, and 60 minutes before dinner, after dinner, and again before bedtime, with each sample being 2ml (a total of four times, with a permanent indwelling needle). Ghrelin is detected through these blood samples.
Total Sleep Duration
Time frame: Total sleep duration will be completed within fifteen days after the volunteers are enrolled.
Total sleep duration will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Sleep Efficiency
Time frame: Sleep efficiency will be completed within fifteen days after the volunteers are enrolled.
Sleep efficiency will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Sleep Cycle Durations
Time frame: Sleep cycle durations will be completed within fifteen days after the volunteers are enrolled.
Sleep cycle durations will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Heart Rate During Sleep
Time frame: Heart rate during sleep will be completed within fifteen days after the volunteers are enrolled.
Heart rate during sleep will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Respiratory Patterns During Sleep
Time frame: Respiratory patterns during sleep will be completed within fifteen days after the volunteers are enrolled.
Respiratory patterns during sleep will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Step Time
Time frame: Step time will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step time.
Step Frequency
Time frame: Step frequency will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step frequency.
Step Speed
Time frame: Step speed will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step speed.
Stride Length
Time frame: Stride length will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for stride length.
Bilateral Gait Symmetry
Time frame: Bilateral gait symmetry will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for bilateral gait symmetry.
Pelvic, Hip and Knee Joint Angle Parameters
Time frame: Pelvic, hip and knee joint Angle parameters will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for pelvic, hip and knee joint angle parameters.
Joint Torque
Time frame: Joint torque will be completed within fifteen days after the volunteers are enrolled.
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for joint torque.
Non-Targeted Microbiome Detection Of Stool Samples
Time frame: The retention of stool samples for non-targeted microbiome detection will be completed within 15 days after the enrollment of volunteers, and the sample analysis will be completed before November 1, 2025.
Non-targeted microbiome studies are a comprehensive and unbiased approach to studying microbial communities. This method uses high-throughput sequencing or mass spectrometry to analyze the genomes (metagenomics) or metabolites (metabolomics) of all microorganisms in a sample, without preconceived targets. Since this study does not have a specific target microorganism, we will collect approximately 10ml of midstream fecal samples from participants for the detection of all microorganisms' genomes (metagenomics) or metabolites (metabolomics).
Non-Invasive Brain Function Monitoring
Time frame: Non-invasive brain function monitoring will be completed within fifteen days after the volunteers are enrolled.
Functional Near-Infrared Spectroscopy (fNIRS) will be used to assess brain activity by measuring changes in oxyhemoglobin and deoxyhemoglobin concentrations. We may use the BS2000 near-infrared imaging system for this purpose. Assessment Areas: Prefrontal cortex, motor cortex, frontal pole, dorsolateral prefrontal cortex, primary motor/somatosensory cortex, premotor and supplementary motor cortex-on both healthy and affected sides. Key Indicators:HbO, HbR, and HbT concentration changes during a 0-40 sec task window. 3D topological maps (HbO beta values). Activation levels at rest. Functional connectivity (HbO).
Cerebral Oxyhemoglobin Concentration
Time frame: Cerebral oxyhemoglobin concentrationn will be completed within fifteen days after the volunteers are enrolled.
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured cerebral oxyhemoglobin concentration.
Cerebral Deoxyhemoglobin Concentration
Time frame: Cerebral deoxyhemoglobin concentration will be completed within fifteen days after the volunteers are enrolled.
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured cerebral deoxygenated concentration.
Total Hemoglobin Concentration In Cerebral Vasculature
Time frame: Total hemoglobin concentration in cerebral vasculature will be completed within fifteen days after the volunteers are enrolled.
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured total hemoglobin concentration in cerebral vasculature
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 33665639Speakman 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.
- Background: PubMed 15394301WEIR 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueying Zhang, PhD principal investigator
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
John R Speakman, PhD principal investigator
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Energy Metabolism and 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 2 inclusion and 9 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 2 Sep 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 (86+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: Height will be measured on the first day after volunteers are enrolled.). The study lists 31 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 NCT07056504, 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 2 Sep 2025.