Technologies and Systems for Assessing Human Energy Metabolism and Nutritional Rehabilitation

NCT07056504 | Recruiting

• 1 other identifier: SIAT-IRB-250615-H0986
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Energy Metabolism; Nutrition, Healthy

Outcome Measures

Primary Outcomes (31)

• Height

  Measured by seca 217 stable stadiometer. Subjects wearing no shoes.

  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.

  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.

  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.

  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 ).

  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.

  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.

  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).

  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. .

  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.

  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）

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  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

  Total hemoglobin concentration in cerebral vasculature will be completed within fifteen days after the volunteers are enrolled.

Study Arms (1)

rehabilitation

Individuals aged 20 to 70 years, who are recovering from stroke or motor injuries

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Male and female participants aged 20 to 70 years old;
• Rehabilitation patients with stroke or motor injuries;

You may not qualify if:

• 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;
• Women in the preconception period, pregnancy, or lactation;
• Uremic patients;
• Inability to lie flat for one hour.

Sponsors & Collaborators

• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: lead

Study Sites (1)

Guangdong Jianxiang Hospital Group

Foshan, Guangdong, 528012, China

RECRUITING

Related Publications (2)

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

  PMID: 33665639 BACKGROUND

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

  PMID: 15394301 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We will collect patients' urine samples to measure energy expenditure, blood samples for metabolomics and hormone level analysis, and fecal samples for microbiome profiling.

Study Officials

• Xueying Zhang, PhD

  Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• John R Speakman, PhD

  Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueying Zhang, Doctor

CONTACT

86+18201296155; zhangxy@siat.ac.cn

Tianyi Wang, Doctor

CONTACT

15367493350; wangtianyi@cmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 9, 2025
• Study Start: July 9, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

CN (1)