Physical ActivityactivityNCT07137520
The Impact of Various Exercise Intensities on Energy Expenditure Metabolism
An observational study of Physical Activity, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effects of physical activity in adult on metabolic response. The main question it aims to answer is: if physical activity is unlimited to increase the total energy expenditure (TEE)? Participants will engage in the following measurements: Record their daily… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Observation without intervention
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of Shenzhen, Guangzhou, China
Who may be able to join
- BMI ≥ 18.5 kg/m2
Who cannot join
- Individuals who have undergone major surgery in the past 6 months (excluding tooth extraction);
- Individuals with severe metabolic and cardiovascular diseases such as diabetes, hypoglycemia, and hypertension;
- Individuals with exercise-related injuries, including joint diseases and fractures;
- Individuals diagnosed with infectious diseases such as HIV, tuberculosis, malaria, etc.;
- Individuals with mental and neurological disorders including anorexia nervosa;
- Individuals who have attempted weight loss or gain through various methods in the past three months;
- Individuals in preconception, pregnancy, and lactation periods;
- Individuals with autism and those with metal implants in their bodies.
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
Shenzhen Institutes of Advanced Technology，Chinese Academy of Sciences
Shenzhen, Guangdong
John R Speakman, 15810868669, j.speakman@abdn.ac.uk
About this study
Official title: An Observational Study on the Relationship Between Different Exercise Intensities and Energy Expenditure Metabolism
The goal of this observational study is to learn about the effects of physical activity in adult on metabolic response. The main question it aims to answer is:
- if physical activity is unlimited to increase the total energy expenditure (TEE)?
Participants will engage in the following measurements:
- Record their daily physical activity by GT3X.
- Measure TEE by doubly-labeled water (DLW) method
- Measure basal energy expenditure(BEE) and thermic effect of food(TEF) by respiratory chamber
Read the detailed description
The purpose of this study is to explore the effect of various physical activities on metabolic and behavior response. Energy expenditure, body composition, and metabolism will be measured by the following measurements:
- TEE:
TEE will be measured using the DLW method. Urine samples from all participants in the DLW subset will be stored at -20℃ and shipped on dry ice for analysis in the laboratory of Prof. John Speakman at the Shenzhen Institutes of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation. TEE will then be calculated using mean CO2 production.
- REE and TEF:
REE and TEF will be measured by indirect calorimetry while participants are resting supine in a respiratory chamber with thermoneutral conditions. Oxygen consumption and CO2 production will be measured to calculate energy expenditure. REE will be consistently measured throughout sleeping at night and in the morning after overnight fasting, and TEF will be measured after breakfast.
- Physical activity：
Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day with less than 12 hours of wear. For a valid measure the goal is to get 2 weekday and 2 weekend days.
- VO2max test:
Participants need to warm up with simple stretching or light aerobic exercise before the test. The test will be conducted on a treadmill. A comfortable running speed acceptable to the participants will be set. The treadmill's incline will be increased by 10% every two minutes until the individual reaches their physical limit and can no longer continue. During this test, a respiratory mask and gas analyzer will be used to measure the concentration of oxygen (O2) and carbon dioxide (CO2) in the breath to calculate VO2max.
- Food intake
Photographic and food weighing methods to record food intake for two random days throughout the period of DLW measurement.
- Blood glucose
Fasting and post-prandial glucose will be recorded by a continuous glucose monitoring system.
- Body composition：
Fat mass will be measured by Magnetic Resonance Imaging (MRI, Shanghai united imaging, uMR 790 ).
Bioimpedance Analysis will measure fat-free mass (Tanita, MC-980). Bone mass will be measured by Dual Energy X-ray Absorptiometry (DXA, Horizon Wi, HOLOGIC).
- Body weight:
At visit 1, fasting body weight will be measured using a calibrated seca at the beginning of the visit. Fasting weight will be measured at visit 2 and, if applicable.
- Height:
Height (to +0.1 cm) will be measured by seca 217 stable without wearing shoes.
- Waist circumference:
Hip and waist circumference (to +0.3 cm) will be measured using a whole body laser scanner.
- Blood pressure:
Systolic and diastolic blood pressure will be measured using an Omron digital sphygmomanometer.
- Conditions
- Physical Activity
- Being tested
- Observation without intervention
- Keywords
- Metabolic response, Energy expenditure, Physical fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation without interventionOther
Observation without intervention
| Study group | Role | What they receive |
|---|---|---|
| Sedentary group | Godin scale score ≥ 24 Receives: Other: Observation without intervention | |
| Moderately active group | 14≥ Godin scale score ≥ 23 Receives: Other: Observation without intervention | |
| Active group | Godin scale score <14 Receives: Other: Observation without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in total energy expenditure (TEE) measured by the doubly labeled water (DLW) method across experimental groups
- The change in TEE will be evaluated using the DLW. Urine samples from all participants in the DLW subset will be stored at -20℃ and shipped on dry ice for analysis in the laboratory of Dr. John Speakman at the University of Aberdeen, or the Shenzhen Institutes of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation (Speakman et al 2021: Cell reports medicine). TEE will then be calculated using mean CO2 production using the Weir equation.
Measured: 14days
Differences in non-exercise physical activity across experimental groups
- Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days.
Measured: 14days
Differences in resting energy expenditure (REE) measured by respiratory chamber across experimental groups
- REE will be evaluated by respiratory chamber.
Measured: 1 day
Differences in thermic effect of food (TEF) measured by respiratory chamber across experimental groups
- TEF will be evaluated by respiratory chamber.
Measured: 1 day
Differences in exercise energy expenditure (EEE) measured by COSMED across experimental groups
- EEE will be evaluated using an indirect calorimetry COSMED.
Measured: 1 hour
Differences in food intake across experimental groups
Photographic and food weighing methods to record food intake for two random days throughout the period of DLW measurement
Measured: 2 days
Secondary outcomes (7)
Differences in sedentary time measured by GT3X accelerometer across experimental groups
- Sedentary time will be represented from the GT3X accelerometer.
Measured: 14 days
Differences in glucose across experimental groups
Fasting and post-prandial glucose will be recorded by a continuous glucose monitoring system.
Measured: 7 days
Differences in fat mass across experimental groups
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Measured: 10 minutes
Differences in fat-free mass across experimental groups
Fat-free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).
Measured: 2 minutes
Differences in bone mass intensity across experimental groups
Bone mass intensity will be measured by DXA( Horizon Wi, HOLOGIC)
Measured: 7 minutes
Differences in circulating hormones across experimental groups
The nurse will collect the fasting blood sample. Metabolomics will analyze circulating hormones and metabolites.
Measured: 1 minutes for collection, 7 days for analysis.
Differences in intestinal microbiota across experimental groups
Feces will be collected for gut microbiome analysis of intestinal microbiota.
Measured: 5 minutes for collection, 7 days for analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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 Physical ActivityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 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, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Investigators
- John R Speakman, PhD, Principal investigator, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137520
- Sponsor's protocol ID
- SIAT-IRB-240615-H0893
- Other IDs
- SIATCAS
- Acronym
- activity
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- 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 33665639Pontzer H, Durazo-Arvizu R, Dugas LR, Plange-Rhule J, Bovet P, Forrester TE, Lambert EV, Cooper RS, Schoeller DA, Luke A. Constrained Total Energy Expenditure and Metabolic Adaptation to Physical Activity in Adult Humans. Curr Biol. 2016 Feb 8;26(3):410-7. doi: 10.1016/j.cub.2015.12.046. Epub 2016 Jan 28.
PubMed 26832439
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Relationship Between Different Exercise Intensities and Energy Expenditure Metabolism
- ClinicalTrials.gov ID
- NCT07137520
- Acronym / sponsor ID
- activity / SIAT-IRB-240615-H0893
- Conditions
- Physical Activity
- Keywords
- Metabolic response, Energy expenditure, Physical fitness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 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 goal of this observational study is to learn about the effects of physical activity in adult on metabolic response. The main question it aims to answer is:
- if physical activity is unlimited to increase the total energy expenditure (TEE)?
Participants will engage in the following measurements:
- Record their daily physical activity by GT3X.
- Measure TEE by doubly-labeled water (DLW) method
- Measure basal energy expenditure(BEE) and thermic effect of food(TEF) by respiratory chamber
Detailed description
The purpose of this study is to explore the effect of various physical activities on metabolic and behavior response. Energy expenditure, body composition, and metabolism will be measured by the following measurements:
- TEE:
TEE will be measured using the DLW method. Urine samples from all participants in the DLW subset will be stored at -20℃ and shipped on dry ice for analysis in the laboratory of Prof. John Speakman at the Shenzhen Institutes of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation. TEE will then be calculated using mean CO2 production.
- REE and TEF:
REE and TEF will be measured by indirect calorimetry while participants are resting supine in a respiratory chamber with thermoneutral conditions. Oxygen consumption and CO2 production will be measured to calculate energy expenditure. REE will be consistently measured throughout sleeping at night and in the morning after overnight fasting, and TEF will be measured after breakfast.
- Physical activity：
Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day with less than 12 hours of wear. For a valid measure the goal is to get 2 weekday and 2 weekend days.
- VO2max test:
Participants need to warm up with simple stretching or light aerobic exercise before the test. The test will be conducted on a treadmill. A comfortable running speed acceptable to the participants will be set. The treadmill's incline will be increased by 10% every two minutes until the individual reaches their physical limit and can no longer continue. During this test, a respiratory mask and gas analyzer will be used to measure the concentration of oxygen (O2) and carbon dioxide (CO2) in the breath to calculate VO2max.
- Food intake
Photographic and food weighing methods to record food intake for two random days throughout the period of DLW measurement.
- Blood glucose
Fasting and post-prandial glucose will be recorded by a continuous glucose monitoring system.
- Body composition：
Fat mass will be measured by Magnetic Resonance Imaging (MRI, Shanghai united imaging, uMR 790 ).
Bioimpedance Analysis will measure fat-free mass (Tanita, MC-980). Bone mass will be measured by Dual Energy X-ray Absorptiometry (DXA, Horizon Wi, HOLOGIC).
- Body weight:
At visit 1, fasting body weight will be measured using a calibrated seca at the beginning of the visit. Fasting weight will be measured at visit 2 and, if applicable.
- Height:
Height (to +0.1 cm) will be measured by seca 217 stable without wearing shoes.
- Waist circumference:
Hip and waist circumference (to +0.3 cm) will be measured using a whole body laser scanner.
- Blood pressure:
Systolic and diastolic blood pressure will be measured using an Omron digital sphygmomanometer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sedentary group | – | Other: Observation without interventionGodin scale score ≥ 24 |
| Moderately active group | – | Other: Observation without intervention14≥ Godin scale score ≥ 23 |
| Active group | – | Other: Observation without interventionGodin scale score <14 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of Shenzhen, Guangzhou, China
Key inclusion criteria (1 listed)
- BMI ≥ 18.5 kg/m2
Key exclusion criteria (8 listed)
- Individuals who have undergone major surgery in the past 6 months (excluding tooth extraction);
- Individuals with severe metabolic and cardiovascular diseases such as diabetes, hypoglycemia, and hypertension;
- Individuals with exercise-related injuries, including joint diseases and fractures;
- Individuals diagnosed with infectious diseases such as HIV, tuberculosis, malaria, etc.;
- Individuals with mental and neurological disorders including anorexia nervosa;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation without interventionObservation without intervention | Other | Active group, Moderately active group, Sedentary group |
Primary outcome
Differences in total energy expenditure (TEE) measured by the doubly labeled water (DLW) method across experimental groups
Time frame: 14days
- The change in TEE will be evaluated using the DLW. Urine samples from all participants in the DLW subset will be stored at -20℃ and shipped on dry ice for analysis in the laboratory of Dr. John Speakman at the University of Aberdeen, or the Shenzhen Institutes of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation (Speakman et al 2021: Cell reports medicine). TEE will then be calculated using mean CO2 production using the Weir equation.
Differences in non-exercise physical activity across experimental groups
Time frame: 14days
- Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days.
Differences in resting energy expenditure (REE) measured by respiratory chamber across experimental groups
Time frame: 1 day
- REE will be evaluated by respiratory chamber.
Differences in thermic effect of food (TEF) measured by respiratory chamber across experimental groups
Time frame: 1 day
- TEF will be evaluated by respiratory chamber.
Differences in exercise energy expenditure (EEE) measured by COSMED across experimental groups
Time frame: 1 hour
- EEE will be evaluated using an indirect calorimetry COSMED.
Differences in food intake across experimental groups
Time frame: 2 days
Photographic and food weighing methods to record food intake for two random days throughout the period of DLW measurement
7 secondary outcomes
Differences in sedentary time measured by GT3X accelerometer across experimental groups
Time frame: 14 days
Differences in glucose across experimental groups
Time frame: 7 days
Differences in fat mass across experimental groups
Time frame: 10 minutes
Differences in fat-free mass across experimental groups
Time frame: 2 minutes
Differences in bone mass intensity across experimental groups
Time frame: 7 minutes
Differences in circulating hormones across experimental groups
Time frame: 1 minutes for collection, 7 days for analysis.
Differences in intestinal microbiota across experimental groups
Time frame: 5 minutes for collection, 7 days for analysis.
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 22 Aug 2025.
- Results publication: 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.
- Results publication: PubMed 26832439Pontzer H, Durazo-Arvizu R, Dugas LR, Plange-Rhule J, Bovet P, Forrester TE, Lambert EV, Cooper RS, Schoeller DA, Luke A. Constrained Total Energy Expenditure and Metabolic Adaptation to Physical Activity in Adult Humans. Curr Biol. 2016 Feb 8;26(3):410-7. doi: 10.1016/j.cub.2015.12.046. Epub 2016 Jan 28.
- A standard calculation methodology for human doubly labeled water studies.Link provided by the sponsor.
- Constrained Total Energy Expenditure and Metabolic Adaptation to Physical Activity in Adult Humans.Link provided by the sponsor.
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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.
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 Physical Activity, 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 8 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: opening soon, as of the sponsor's last update on 22 Aug 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 John R Speakman, PhD (+8615810868669, j.speakman@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in total energy expenditure (TEE) measured by the doubly labeled water (DLW) method across experimental groups (time frame: 14days). The study lists 6 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 NCT07137520, 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 22 Aug 2025.