Physical InactivityNCT07893249
Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention
A study testing Supervised Aerobic Exercise Programme in people with Physical Inactivity and Overweight, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
This prospective, single-arm interventional study will investigate why adults receiving the same prescribed dose and relative intensity of exercise show divergent changes in energy balance, body weight, and body composition. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Overweight, Obesity
- What is being tested?
- Supervised Aerobic Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2026to 31 Dec 2030
- Phase
- Interventional
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary individuals
- BMI ≥ 24 kg/m2
- Chinese male and female adults
- Normal electrocardiogram (ECG)
Who cannot join
- Individuals who have undergone major surgery within the past 6 months (tooth extraction excluded);
- Individuals with cardiovascular diseases (e.g., hypertension) and severe
- metabolic diseases requiring continuous medication (e.g., diabetes);
- Exercise-induced injuries, including joint diseases, fractures, etc.;
- Individuals with infectious diseases, such as HIV/AIDS, tuberculosis, malaria, etc.;
- Psychiatric and neurological disorders, such as anorexia nervosa, etc.;
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- Individuals who have attempted weight loss or weight gain through various means within the past three months;
- Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period
- Individuals with claustrophobia or metallic implants in the body which are incompatible with MRI measurements
- Individuals who have used antibiotics, probiotics, oral laxatives, etc., within eight weeks;
- Individuals with a history of hemophobia or needle phobia.
- Individuals who have been drinking deuterium depleted water which is incompatible with the DLW measures.
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
About this study
Official title: Personal Healthcare: Maxmising the Benefits of Exercise by Understanding the Mechanisms of Metabolic Compensation
This prospective, single-arm interventional study will investigate why adults receiving the same prescribed dose and relative intensity of exercise show divergent changes in energy balance, body weight, and body composition. A total of 150 sedentary Chinese adults aged 18-40 years with overweight or obesity will complete a 12-week, supervised treadmill exercise programme. Exercise will be performed five times per week at an intensity corresponding to 60% of each participant's measured maximal oxygen uptake. Prescribed exercise energy expenditure will increase progressively from 150 kcal per session in Weeks 1-4 to 250 kcal per session in Weeks 5-8 and 350 kcal per session in Weeks 9-12.
The primary objective is to quantify inter-individual variability in energy compensation after the standardized intervention. Detailed measurements will characterize total and resting energy expenditure, energy intake, appetite, physical activity, body composition, glucose dynamics, cardiorespiratory fitness, brain responses to food-related stimuli, and molecular phenotypes. Multi-omics analyses will include gut microbiome, metabolomic, proteomic, extracellular-vesicle, peripheral blood mononuclear cell, and transcriptomic assessments. The study will explore physiological, behavioral, and molecular factors associated with divergent compensatory responses. No randomized comparator group is included; therefore, causal comparisons between exercise and non-exercise conditions are outside the study scope.
Read the detailed description
Background and rationale
Individuals differ markedly in body-weight and fat-mass responses to apparently equivalent exercise programmes. This variability may reflect compensatory adaptations in other components of energy balance, including changes in non-exercise physical activity, resting energy expenditure, dietary energy intake, appetite, substrate metabolism, and neurobehavioral responses to food. Molecular and microbial phenotypes may further contribute to these divergent responses. A standardized intervention combined with detailed longitudinal phenotyping can identify response patterns and generate candidate predictors of energy compensation.
Study objectives
Primary objective:
To quantify inter-individual variability in energy compensation from baseline to the end of a 12-week supervised exercise intervention.
Secondary objectives:
- To characterize changes in body weight, fat mass, fat-free mass, total energy expenditure, resting energy expenditure, energy intake, appetite, glucose regulation, cardiorespiratory fitness, and physical activity.
- To determine whether baseline physiological, behavioral, neuroimaging, microbial, metabolomic, proteomic, extracellular-vesicle, immune-cell, and transcriptomic characteristics are associated with the magnitude or direction of energy compensation.
- To explore biological pathways that distinguish participants showing low, moderate, or high compensatory responses.
- To assess adherence to and safety of the supervised exercise programme.
Study procedures
After screening and written informed consent, eligible participants will undergo baseline assessments. These may include anthropometry, body composition, dual-energy X-ray absorptiometry, magnetic resonance imaging, indirect calorimetry, maximal oxygen uptake testing, doubly labeled water assessment, respiratory-chamber assessment, continuous glucose monitoring, standardized food-intake and appetite assessments, physical-activity monitoring, functional magnetic resonance imaging, electroencephalography, and biological sample collection.
Cardiovascular assessments may include 24-hour ambulatory blood pressure monitoring, resting electrocardiography, and peripheral endothelial function measured using EndoPAT. Arterial stiffness and peripheral arterial status may be assessed using brachial-ankle pulse wave velocity and the ankle-brachial index. Carotid vascular structure may be assessed using ultrasonography. Cardiac structure, ventricular function, myocardial strain, and tissue characteristics may be evaluated using transthoracic echocardiography and cardiac magnetic resonance imaging.
Core body temperature, tympanic temperature, and ambient temperature will be continuously monitored using an e-Celsius ingestible capsule, a VitThermo in-ear monitor, and an iButton temperature logger, respectively.
Participants will then complete a 12-week supervised treadmill exercise intervention. Each session will be prescribed at 60% of the participant's measured maximal oxygen uptake. Exercise duration will be adjusted to achieve the prescribed energy expenditure. The prescribed dose will be 150 kcal per session during Weeks 1-4, 250 kcal per session during Weeks 5-8, and 350 kcal per session during Weeks 9-12. Participants will complete five supervised sessions per week. Cardiorespiratory fitness will be reassessed at prespecified intervals, allowing workload adjustment to maintain the intended relative exercise intensity.
Selected assessments will be repeated at prespecified interim visits, at the completion of the intervention in Week 12, and during the follow-up assessment in Week 24. Blood, urine, and fecal samples will be collected at designated time points.
Biological samples may undergo microbiome, metabolomic, proteomic, extracellular-vesicle, peripheral blood mononuclear cell, bulk RNA-sequencing, and selected single-cell RNA-sequencing analyses. These analyses will be exploratory and interpreted using appropriate multiple-testing correction and validation procedures.
- Conditions
- Physical Inactivity, Overweight, Obesity
- Being tested
- Supervised Aerobic Exercise Programme
- Keywords
- Exercise, Energy Compensation, Individual Variability
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic Exercise ProgrammeBehavioural
Also called Exercise training; treadmill exercise; aerobic training
Participants will perform supervised treadmill exercise five days per week for 12 weeks. Each session will be conducted at 60% of the participant's measured maximal oxygen uptake. The prescribed exercise energy expenditure will be 150 kcal per session in Weeks 1-4, 250 kcal per session in Weeks 5-8, and 350 kcal per session in Weeks 9-12. Session duration will be adjusted individually to meet the energy-expenditure target. Maximal oxygen uptake will be reassessed at prespecified intervals, provisionally at baseline and Weeks 4, 8, and 12, to maintain the prescribed relative intensity. Attendance, completed exercise dose, heart rate, adverse symptoms, and protocol deviations will be documented.
150 Kcal for Weeks 1-4 (gradually increase to 150 Kcal in the first two weeks as familiar stage), 250 Kcal for Weeks 5-8, 350 Kcal for Weeks 9-12.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Structured Aerobic Exercise | Experimental | All enrolled participants will receive the same progressive, 12-week supervised treadmill exercise programme. The relative exercise intensity will be standardized at 60% of measured maximal oxygen uptake, Actual intensity will be also tested during the first interventional session of each month, while session duration will be individualized to achieve the prescribed energy expenditure. Receives: Behavioral: Supervised Aerobic Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy compensation after the 12-week supervised exercise intervention
Exercise energy compensation (ExEC), expressed in percentage, will be calculated as [(ExEE plus change in body energy stores) divided by ExEE] multiplied by 100. ExEE will be calculated from completed supervised exercise sessions. Change in body energy stores will be derived from changes in fat mass and fat-free mass between baseline and Week 12 and divided by the intervention duration. A value of 0% indicates no compensation, whereas 100% indicates complete compensation for the exercise-induced energy expenditure.
Measured: Baseline to Week 12
Secondary outcomes (39)
Change in body weight
Difference in measured body weight in kilograms relative to baseline.
Measured: Weekly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).
Change in body composition
Difference in body composition will be measured by the prespecified body-composition method. Dual-energy X-ray absorptiometry will be used for the principal endpoint if confirmed; bioelectrical impedance will be used for interim monitoring. Changes in abdominal subcutaneous adipose tissue, visceral adipose tissue, organ-specific fat depots, and the volume or size of prespecified organs will be quantified using magnetic resonance imaging.Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in energy expenditure
Difference in average daily total energy expenditure will be measured using doubly labeled water. Changes in 24-hour energy expenditure, sleeping energy expenditure, resting energy expenditure, and the thermic effect of food will be measured by whole-room indirect calorimetry in a human metabolic chamber. Exercise energy expenditure and excess post-exercise oxygen consumption (EPOC) will be assessed by indirect calorimetry using a COSMED. Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in ad libitum energy intake
Difference in energy intake, measured during the free-living conditions and laboratory meal assessment. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in hunger rating
Hunger will be assessed using a 100-mm visual analogue scale in response to the question "How hungry do you feel?" The scale is anchored by "I am not hungry at all" at 0 mm and "I have never been more hungry" at 100 mm. The distance from the left end of the scale to the participant's mark will be measured in millimeters. The mean of all valid hunger ratings collected during each assessment period will be calculated. Higher scores indicate greater perceived hunger. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in neural responses to food-related stimuli
Neural activation characteristics of reward-related and energy homeostasis-regulating brain regions during the selection of foods with varying energy densities and macronutrient compositions, assessed by fMRI and EEG.Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in maximal oxygen uptake
Maximal oxygen uptake will be measured during a graded treadmill exercise test using a respiratory gas-analysis system. Relative maximal oxygen uptake will be expressed in mL/kg/min. Changes at each post-baseline assessment will be evaluated relative to baseline.
Measured: Monthly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).
Change in free-living physical activity
Difference in accelerometer-derived physical activity using prespecified valid-wear criteria. Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean interstitial glucose
Mean interstitial glucose will be calculated over the valid continuous glucose monitoring period and expressed in mmol/L. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean amplitude of glycemic excursions
The mean amplitude of glycemic excursions (MAGE) will be calculated from valid continuous glucose monitoring data and expressed in mmol/L. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in glucose coefficient of variation
The glucose coefficient of variation will be calculated as the standard deviation of glucose divided by mean glucose and multiplied by 100. It will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in resting blood pressure
Resting blood pressure will be measured in mmHg using electronic blood pressure monitor sphygmomanometer and watch after 10 minutes of rest and after both the energy consumption test and the endurance test. Changes at Week 4,8,12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in 24 hours ambulatory blood pressure
Blood pressure will be measured using a blood pressure monitor. Systolic and diastolic blood pressure during the daytime and nighttime will be calculated from valid blood pressure readings and expressed in millimeters of mercury (mmHg). Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in reactive hyperemia index
Vascular endothelial function will be assessed using EndoPAT by measuring changes in peripheral arterial tone during reactive hyperemia. The reactive hyperemia index (RHI) will be calculated automatically using the device-specific algorithm and expressed as a ratio. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in arterial stiffness
Arterial stiffness will be assessed non-invasively by measuring brachial-ankle pulse wave velocity (baPWV). baPWV will be calculated as the estimated arterial path length divided by pulse transit time and expressed in meters per second (m/s). Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in carotid vascular structure
Carotid vascular structure will be assessed non-invasively using carotid ultrasonography. Carotid intima-media thickness (CIMT) will be measured as the distance between the lumen-intima and media-adventitia interfaces of the carotid artery wall and expressed in millimeters (mm). Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in cardiac electrical activity
Resting cardiac electrical activity will be assessed using an electrocardiographic monitoring device. Electrocardiographic parameters, including PR interval, QRS duration and QT interval will be derived from recorded ECG signals and expressed in milliseconds (ms) for ECG intervals. Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume (LVEDV) will be measured using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular End-Systolic Volume (LVESV)
Left ventricular end-systolic volume (LVESV) will be measured using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Stroke Volume (LVSV)
Left ventricular stroke volume (LVSV) will be calculated as the difference between left ventricular end-diastolic and end-systolic volumes obtained using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction (LVEF) will be calculated as the difference between end-diastolic volume (EDV) and end-systolic volume (ESV), divided by EDV and multiplied by 100. EDV and ESV will be obtained using cardiac magnetic resonance (CMR) cine imaging. LVEF will be expressed as a percentage (%).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Myocardial Mass
Left ventricular myocardial mass will be quantified using cardiac magnetic resonance (CMR) cine imaging and expressed in grams (g).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Global Longitudinal Strain (GLS)
Left ventricular global longitudinal strain (GLS) will be assessed using feature-tracking analysis of cardiac magnetic resonance (CMR) cine images and expressed as a percentage (%).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Myocardial Native T1 Relaxation Time
Myocardial native T1 relaxation time will be measured using cardiac magnetic resonance (CMR) T1 mapping sequences and expressed in milliseconds (ms).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Myocardial T2 Relaxation Time
Myocardial T2 relaxation time will be measured using cardiac magnetic resonance (CMR) T2 mapping sequences and expressed in milliseconds (ms).Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular E/e' Ratio
The ratio of early mitral inflow velocity (E) to the average early diastolic mitral annular velocity (e') will be measured using transthoracic echocardiography (TTE) with Doppler imaging and reported as a dimensionless value. Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Adherence to the exercise intervention
Number and percentage of prescribed sessions completed and percentage of prescribed exercise energy expenditure achieved.
Measured: From the first exercise session through Week 12
Change in body circumferences
Changes in whole body circumferences will be quantified in centimeters using a three-dimensional body scanner. Changes in each measured circumference will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in heart rate and heart rate variability
Changes in heart rate and heart rate variability will be assessed using the prespecified wearable monitoring devices. Resting, exercise, post-exercise, and free-living heart rate will be expressed in beats per minute. Prespecified time-domain and frequency-domain heart rate variability indices will be derived from valid interbeat-interval recordings. Changes at Week 12 and 24 will be assessed relative to baseline.
Measured: Baseline, during the 12-week intervention, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in total fatigue assessment scale score
Fatigue will be assessed using the 10-item Fatigue Assessment Scale (FAS). Each item evaluates how frequently the participant usually experiences a fatigue-related symptom and is rated on a 5-point scale: 1 (never), 2 (sometimes), 3 (regularly), 4 (often), and 5 (always). Items 4 and 10 will be reverse-scored. The 10 item scores will be summed to produce a total score ranging from 10 to 50, with higher scores indicating greater fatigue. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in energy rating
Momentary overall energy will be assessed using Item 1 of the Daytime Energy Data Collection Momentary Energy Questionnaire. Participants will rate their current overall energy level on a 7-point scale ranging from 1 (completely drained) to 7 (peak state). The mean of all valid ratings collected during each assessment period will be calculated. Higher scores indicate a higher perceived energy level. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Changes in the global score and prespecified component scores will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in average nightly sleep efficiency measured by actigraphy
Sleep will be monitored using an ActiGraph GT3XP-BTLE triaxial accelerometer. Sleep efficiency will be calculated as total sleep time divided by time in bed and multiplied by 100. The average sleep efficiency across all valid monitoring nights during each assessment period will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Fourteen-day monitoring periods at baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in average sleep efficiency measured using the ISHO ring
Sleep will be monitored using the ISHO ring. Sleep efficiency will be calculated using the device-specific algorithm as total sleep time divided by time in bed and multiplied by 100. The average sleep efficiency across all valid monitoring nights during each assessment period will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Throughout from baseline to Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).
Change in MRI-derived slow-twitch muscle fiber proportion in the soleus
The proportion of slow-twitch muscle fibers in the soleus will be estimated using the prespecified magnetic resonance imaging. The slow-twitch muscle fiber proportion will be expressed as a percentage of the assessed soleus muscle tissue. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in MRI-derived slow-twitch muscle fiber proportion in the gastrocnemius
The proportion of slow-twitch muscle fibers in the gastrocnemius will be estimated using the prespecified magnetic resonance imaging. The slow-twitch muscle fiber proportion will be expressed as a percentage of the assessed gastrocnemius muscle tissue. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean core body temperature
Core body temperature will be continuously measured using an ingestible e-Celsius temperature capsule (BodyCap). Recording will begin after the capsule reaches the gastrointestinal tract. The mean of all valid temperature readings collected during each monitoring period will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C).
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean tympanic temperature
Tympanic temperature will be continuously measured using a VitThermo (SKINOS, VTB-01) temperature monitor. The mean of all valid temperature readings collected during each monitoring period will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C).
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean ambient temperature exposure
Ambient temperature exposure will be measured using an iButton (DS1921G). The device will record the temperature of the participant's surrounding environment during each monitoring period. The mean of all valid temperature readings will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C).
Measured: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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
- 150 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, Principal investigator, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893249
- Sponsor's protocol ID
- SIAT-IRB-260915-H1120
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yegian AK, Pachus E, Redman LM, Heymsfield SB, Falkenhain K, Harris AR, Chacko SK, Wong WW, Lieberman DE. Longitudinal and cross-sectional evidence that daily resting and activity energy expenditures are independent in humans. J Physiol. 2026 Jul;604(14):5952-5967. doi: 10.1113/JP291108. Epub 2026 Jun 25.
PubMed 42349903Pontzer 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 26832439Careau V, Halsey LG, Pontzer H, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Das SK, Cooper R, Dugas LR, Eaton SD, 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, 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, Reilly JJ, 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, Luke AH, Rood J, Sagayama H, Schoeller DA, Wong WW, Yamada Y, Speakman JR; IAEA DLW database group. Energy compensation and adiposity in humans. Curr Biol. 2021 Oct 25;31(20):4659-4666.e2. doi: 10.1016/j.cub.2021.08.016. Epub 2021 Aug 27.
PubMed 34453886Speakman 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, Trexler ET. The evidence for constrained total energy expenditure in humans and other animals. Curr Biol. 2026 Feb 23;36(4):1013-1025.e4. doi: 10.1016/j.cub.2026.01.025. Epub 2026 Feb 6.
PubMed 41653928