Trial · NCT07893249
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Energy compensation after the 12-week supervised exercise intervention | Baseline to Week 12 | 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. |
| Secondary | Change in body weight | Weekly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention). | Difference in measured body weight in kilograms relative to baseline. |
| Secondary | Change in body composition | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in energy expenditure | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in ad libitum energy intake | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in hunger rating | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in neural responses to food-related stimuli | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in maximal oxygen uptake | Monthly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in free-living physical activity | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Difference in accelerometer-derived physical activity using prespecified valid-wear criteria. Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in mean interstitial glucose | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in mean amplitude of glycemic excursions | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in glucose coefficient of variation | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in resting blood pressure | Baseline, Week 4, Week 8, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in 24 hours ambulatory blood pressure | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in reactive hyperemia index | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in arterial stiffness | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in carotid vascular structure | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in cardiac electrical activity | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in Left Ventricular End-Diastolic Volume (LVEDV) | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
| Secondary | Change in Left Ventricular End-Systolic Volume (LVESV) | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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