Energy ExpenditureNCT06432517
Sources and Mechanisms of Energy Compensation
A study testing Power Bike（Ergoselect 100P） in people with Energy Expenditure and Exercise, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
Excess energy, obesity and obesity-related diseases are important global health issues. Although it is known that obesity is an issue of energy balance, the components of energy expenditure seem to be inter-related in complex non-additive ways. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Exercise, Energy Intake
- What is being tested?
- Power Bike（Ergoselect 100P）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 30 Dec 2025
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (men)
- 18-40 years old
- BMI (body mass index)≥18.5 kg/m2
Who cannot join
- Those who have undergone surgery in the past 6 months.
- People are requiring long-term medication.
- People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
- People have digestive diseases, like gastric ulcer, pancreatitis, Intestinal obstruction, et al.
- People have sports injury, like fracture, Joint injury, et al.
- Those who have recently lost weight for various medical reasons (e.g. cancer, etc.).
Show all 11Show fewer
- People are losing weight by tablets.
- People are suffering from infectious diseases (e.g. HIV, etc.)
- People have blood phobia, pathological hypo or hyper tension.
- People with impaired glucose tolerance.
- Those who are afflicted with claustrophobia.
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
Shenzhen Institute of Advanced Technology
Shenzhen, Guangdong
John R Speakman, PhD, +8615810868669, j.speakman@abdn.ac.uk
About this study
Official title: Identification of the Sources and Mechanisms of Energy Compensation in Humans
Excess energy, obesity and obesity-related diseases are important global health issues. Although it is known that obesity is an issue of energy balance, the components of energy expenditure seem to be inter-related in complex non-additive ways. The aim of this study is to explore the downstream impacts of exercise on short term changes in both expenditure and energy intake. The primary question the investigators are asking is whether moderate to high intensity exercise influences the basal energy expenditure and/or energy intake/macronutrient preference in young adult males? (A similar study will be performed on females in a different registration). The investigators will use a specially designed feeding table to measure energy intake and macronutrient intake, which is easy to quantify intake compensation. Basal metabolism will be measured by hood indirect calorimetry. The investigators will explore the factors that influence the level of compensation in expenditure and intake, in particular body composition. Participants will be asked to come to the lab after 10 hours fast for body composition tests including Dual Energy X-ray Absorptiometry(DXA), Magnetic Resonance Image(MRI) and Bioelectrical Impedance Analysis(BIA). They will then be asked (not) to do 30 minutes of moderate-to-vigorous exercise after an energy-limiting breakfast, during which metabolic rate levels and changes in dietary composition will be recorded by gas exchange and standardized buffet. In addition, participants' subjective hunger and preferences will also be recorded by questionnaires. Venous blood will be collected to measure metabolic and hormone factors, blood glucose will be measured by Continuous Blood Glucose Monitor (CGM).
Read the detailed description
81 participants will be recruited by posters and Wechat. The sample size is calculated using the paired t-test in power analysis, in which α value is 0.05, β value is 0.8, standard deviation is 372 (calculated from the energy intake data in the preliminary trial), and the difference is 108. The alternative hypothesis is greater than 108. The experiment lasted for 14 days, of which two and a half days will be carried out in the laboratory, and the other time only need to wear devices and live freely, which will not affect the normal life. The experiment is mainly divided into three parts:
- Body composition: Items include weight, height, body fat mass (MRI), bone mass (DAX), body density (BODPOD), lean mass (MRI) and 3D parameters (3D scan). The participants will be required to fasting for at least 10 hours. After the test, they will be equipped with continuous glucose monitoring equipment (CGM), motion monitoring equipment (GT3X) and ambient temperature monitoring equipment (ibutton).
- Controlled trial: The specific detection contents include resting energy expenditure (REE), active energy expenditure (AEE) and energy intake. The investigators will provide participants with three meals, as an energy restricted breakfast, a standard lunch and supper for dietary component testing. The subjective hunger and eating preference rate of participants will be measured by Visual Analogue Scale (VAS) and questionnaires. Non-physical activities such as working, reading and watching movies will be allowed during the experiment. Venous blood will be collected at several specific points (fasting 10 hours, after breakfast, before lunch and after lunch). In addition, sweat, urine and feces will also be collected.
- Exercise trial: The schedule is the same as the control trial except for Blood drawing time and 30 minutes of power bike after breakfast, the intensity is 100 watt with 1 minute 25 watt break every 5 minute during the exercise. Venous blood will be collected at several specific points in time (just after exercise, before lunch and after lunch).
- Conditions
- Energy Expenditure, Exercise, Energy Intake, Food Preferences
- Being tested
- Power Bike（Ergoselect 100P）
- Keywords
- Energy compensation, Energy balance, Food Preferences
- Medical subject headings
- Motor Activity, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Bike（Ergoselect 100P）Other
Changes in the participants' energy balance will be measured through moderate to high intensity exercise. Observation of food intake, body composition, metabolic rate, food assimilation rate.
| Study group | Role | What they receive |
|---|---|---|
| Moderate to high intensity exercise | Experimental | BMI≥18.5, age between 18-40 years old, 81subjects. Receives: Other: Power Bike（Ergoselect 100P） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macronutrient preference
Macronutrients preference will be recorded by the feeding table, macronutrient preference will be calculated in percentage(%).
Measured: During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.
Energy intake
Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in kilojoule (KJ).
Measured: During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.
Basal metabolic rate
Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and carbon dioxide production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.
Measured: The detection time spans over two days, the control day and the exercise day, from 8:00 am to 5:00 pm, with tests being conducted every hour and each test lasting for half an hour.
Secondary outcomes (15)
Blood glucose
Blood glucose will be recorded by the continuous glucose monitoring system(CGM) in mmol/L.
Measured: Wear it for a total of 4 consecutive days, including the physical examination day, the control day, the exercise day, and the day following the exercise day.
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 where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days.
Measured: Wear it for 14 days from the physical examination day
Ambient temperature
The iButton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment in centigrade(℃). The iButtons can be affixed to the hand bag (or clothes) to measure the subject exposure temperature, an indoor wall of home and workplace, and the building outside to measure the outdoor temperature using a strip of adhesive, water resistant, medical grade tape.
Measured: Wear it for 14 days from the physical examination day
Circulating Biochemical indexes and hormones
Levels of circulating hormones (including leptin, insulin, ghrelin etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L.
Measured: The venous blood of volunteers will be collected 10 times on control and exercise days. (Control day: fasting, 1,2,3,4 hours after breakfast and 2 hours after lunch. Exercise day: 0,1,2 hours after exercise and 2 hours after lunch)
Exercise
Physical activity will be carried out by the Ergoselect 100P(Power bike) at 100 watts
Measured: 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.
Exercise metabolic rate
Basal metabolic rate will be recorded by the Quark PFT ergo, The energy expenditure will be calculated in kilojoule (kj).
Measured: 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.
Weight
Volunteers will be asked to fast for 10 hours and measured fasting weight (kilogram, kg) with light clothes and no shoes.
Measured: On the first morning of the experiment, it last for 10 minutes.
Height
Height will be measured by seca 217 stable stadiometer in meter(m).
Measured: On the first morning of the experiment, it last for 10 minutes.
Waist circumferences
Waist circumferences will be measured using a whole body laser scanner in centimeter(cm).
Measured: On the first morning of the experiment, it last for 15 minutes.
Hip circumferences
Hip circumferences will be measured using a whole body laser scanner in centimeter(cm).
Measured: On the first morning of the experiment, it last for 15 minutes.
Bone mineral density
Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Measured: On the first morning of the experiment, it last for 8 minutes.
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). and Bioimpedance Analysis (Tanita, MC-980).
Measured: On the first morning of the experiment, it last for 30 minutes.
Fat free mass
Fat free mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). and Bioimpedance Analysis (Tanita, MC-980).
Measured: On the first morning of the experiment, it last for 30 minutes.
Blood pressure
Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
Measured: On both the control and exercise days, blood pressure will be measured prior to the basic energy expenditure(≈8:00 am), it last for 5 minutes.
Body temperature
Body temperature will be measured during lunch using a thermal imager（Fluke RSE600）in centigrade(℃).
Measured: On both the control and exercise days, the change of body temperature will be measured during lunchtime and suppertime, each test lasting for 40 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start20 May 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 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 Speakman, Study chair, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432517
- Sponsor's protocol ID
- SIAT-IRB-230515-H0653
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Sources and Mechanisms of Energy Compensation in Humans
- ClinicalTrials.gov ID
- NCT06432517
- Acronym / sponsor ID
- SIAT-IRB-230515-H0653
- Conditions
- Energy Expenditure, Exercise, Energy Intake, Food Preferences
- Keywords
- Energy compensation, Energy balance, Food Preferences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 May 2024 (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.
Excess energy, obesity and obesity-related diseases are important global health issues. Although it is known that obesity is an issue of energy balance, the components of energy expenditure seem to be inter-related in complex non-additive ways. The aim of this study is to explore the downstream impacts of exercise on short term changes in both expenditure and energy intake. The primary question the investigators are asking is whether moderate to high intensity exercise influences the basal energy expenditure and/or energy intake/macronutrient preference in young adult males? (A similar study will be performed on females in a different registration). The investigators will use a specially designed feeding table to measure energy intake and macronutrient intake, which is easy to quantify intake compensation. Basal metabolism will be measured by hood indirect calorimetry. The investigators will explore the factors that influence the level of compensation in expenditure and intake, in particular body composition. Participants will be asked to come to the lab after 10 hours fast for body composition tests including Dual Energy X-ray Absorptiometry(DXA), Magnetic Resonance Image(MRI) and Bioelectrical Impedance Analysis(BIA). They will then be asked (not) to do 30 minutes of moderate-to-vigorous exercise after an energy-limiting breakfast, during which metabolic rate levels and changes in dietary composition will be recorded by gas exchange and standardized buffet. In addition, participants' subjective hunger and preferences will also be recorded by questionnaires. Venous blood will be collected to measure metabolic and hormone factors, blood glucose will be measured by Continuous Blood Glucose Monitor (CGM).
Detailed description
81 participants will be recruited by posters and Wechat. The sample size is calculated using the paired t-test in power analysis, in which α value is 0.05, β value is 0.8, standard deviation is 372 (calculated from the energy intake data in the preliminary trial), and the difference is 108. The alternative hypothesis is greater than 108. The experiment lasted for 14 days, of which two and a half days will be carried out in the laboratory, and the other time only need to wear devices and live freely, which will not affect the normal life. The experiment is mainly divided into three parts:
- Body composition: Items include weight, height, body fat mass (MRI), bone mass (DAX), body density (BODPOD), lean mass (MRI) and 3D parameters (3D scan). The participants will be required to fasting for at least 10 hours. After the test, they will be equipped with continuous glucose monitoring equipment (CGM), motion monitoring equipment (GT3X) and ambient temperature monitoring equipment (ibutton).
- Controlled trial: The specific detection contents include resting energy expenditure (REE), active energy expenditure (AEE) and energy intake. The investigators will provide participants with three meals, as an energy restricted breakfast, a standard lunch and supper for dietary component testing. The subjective hunger and eating preference rate of participants will be measured by Visual Analogue Scale (VAS) and questionnaires. Non-physical activities such as working, reading and watching movies will be allowed during the experiment. Venous blood will be collected at several specific points (fasting 10 hours, after breakfast, before lunch and after lunch). In addition, sweat, urine and feces will also be collected.
- Exercise trial: The schedule is the same as the control trial except for Blood drawing time and 30 minutes of power bike after breakfast, the intensity is 100 watt with 1 minute 25 watt break every 5 minute during the exercise. Venous blood will be collected at several specific points in time (just after exercise, before lunch and after lunch).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to high intensity exercise | Experimental | Other: Power Bike（Ergoselect 100P）BMI≥18.5, age between 18-40 years old, 81subjects. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults (men)
- 18-40 years old
- BMI (body mass index)≥18.5 kg/m2
Key exclusion criteria (11 listed)
- Those who have undergone surgery in the past 6 months.
- People are requiring long-term medication.
- People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
- People have digestive diseases, like gastric ulcer, pancreatitis, Intestinal obstruction, et al.
- People have sports injury, like fracture, Joint injury, et al.
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 |
|---|---|---|
| Power Bike（Ergoselect 100P）Changes in the participants' energy balance will be measured through moderate to high intensity exercise. Observation of food intake, body composition, metabolic rate, food assimilation rate. | Other | Moderate to high intensity exercise |
Primary outcome
Macronutrient preference
Time frame: During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.
Macronutrients preference will be recorded by the feeding table, macronutrient preference will be calculated in percentage(%).
Energy intake
Time frame: During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.
Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in kilojoule (KJ).
Basal metabolic rate
Time frame: The detection time spans over two days, the control day and the exercise day, from 8:00 am to 5:00 pm, with tests being conducted every hour and each test lasting for half an hour.
Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and carbon dioxide production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.
15 secondary outcomes
Blood glucose
Time frame: Wear it for a total of 4 consecutive days, including the physical examination day, the control day, the exercise day, and the day following the exercise day.
Physical activity
Time frame: Wear it for 14 days from the physical examination day
Ambient temperature
Time frame: Wear it for 14 days from the physical examination day
Circulating Biochemical indexes and hormones
Time frame: The venous blood of volunteers will be collected 10 times on control and exercise days. (Control day: fasting, 1,2,3,4 hours after breakfast and 2 hours after lunch. Exercise day: 0,1,2 hours after exercise and 2 hours after lunch)
Exercise
Time frame: 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.
Exercise metabolic rate
Time frame: 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.
Weight
Time frame: On the first morning of the experiment, it last for 10 minutes.
Height
Time frame: On the first morning of the experiment, it last for 10 minutes.
Waist circumferences
Time frame: On the first morning of the experiment, it last for 15 minutes.
Hip circumferences
Time frame: On the first morning of the experiment, it last for 15 minutes.
Bone mineral density
Time frame: On the first morning of the experiment, it last for 8 minutes.
Fat mass
Time frame: On the first morning of the experiment, it last for 30 minutes.
Fat free mass
Time frame: On the first morning of the experiment, it last for 30 minutes.
Blood pressure
Time frame: On both the control and exercise days, blood pressure will be measured prior to the basic energy expenditure(≈8:00 am), it last for 5 minutes.
Body temperature
Time frame: On both the control and exercise days, the change of body temperature will be measured during lunchtime and suppertime, each test lasting for 40 minutes.
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 15 Aug 2025.
- Individual participant dataSharing planned: No
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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 Speakman study chair
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?
A study testing Power Bike（Ergoselect 100P） in people with Energy Expenditure and Exercise, 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 3 inclusion and 11 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 15 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 (+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?
Macronutrient preference (time frame: During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.