Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432517
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-02
Brief Title:
Sources and Mechanisms of Energy Compensation
Sponsor:
Shenzhen Institute of Advanced Technology Chinese Academy of Sciences
Organization:
Shenzhen Institute of Advanced Technology Chinese Academy of Sciences
Study Overview
Official Title:
Identification of the Sources and Mechanisms of Energy Compensation in Humans
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 andor energy intakemacronutrient 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 AbsorptiometryDXA Magnetic Resonance ImageMRI and Bioelectrical Impedance AnalysisBIA 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 005 β value is 08 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
1 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
2 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
3 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
1 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
2 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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None