Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453564
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-17
Brief Title:
Cross Validation of Body Composition Measurement
Sponsor:
John R Speakman
Organization:
Shenzhen Institute of Advanced Technology Chinese Academy of Sciences
Study Overview
Official Title:
Cross Validation of Body Composition Measurement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Obesity as a chronic disease has emerged as one of the most pressing health concerns in the 21st century According to statistics over 21 billion individuals worldwide are affected by overweight or obesity It is worth noting that obesity ranks fifth among the leading causes of mortality globally Body fat percentage fat serves as an accurate measure for evaluating body fat content which can be further categorized into subcutaneous fat intra-abdominal fat and intra-organ fat Subcutaneous fat primarily functions in heat preservation and energy storage while intra-abdominal fat plays a crucial role in safeguarding internal organs from harm Visceral fat deposition mainly occurs due to intracellular lipid degeneration within organ cells Extensive research has demonstrated significant variations in metabolic indications and risks associated with different types of fats across various body regions Therefore precise segmentation and quantification of overall body fat composition and its distribution hold immense significance for studying individual obesity characteristics predicting health outcomes facilitating clinical diagnosis and devising effective treatment strategies However it should be noted that current instruments used for measuring body composition exhibit varying levels of accuracy Henceforth this study aims to cross-validate several commonly employed body composition analyzers including DXA Dual-energy X-ray Absorptiometry BIA Bioelectrical Impedance Analysis BODPOD Air Displacement Plethysmography MRI Magnetic Resonance Imaging deuterium dilution technique and 3D laser scanning techniques to assess their agreement and discrepancies when measuring different aspects of body composition
Detailed Description:
Cross validation of body composition measurement
Body composition will be measured by the following methods
The fasting body weight and height were measured using the Seca medical metric system Seca 311231 Germany Volunteers were instructed to wear a standardized disposable lab coat and stand barefoot on an electronic scale for accurate measurements Barefoot height was measured to the nearest millimeter using a commercially available Leicester stadiometer Seca 217 Germany Volunteers were positioned in the center of the 3D scanning room Scanatic 360 and instructed to maintain proper posture while our scanning staff operated the scanner sensor and camera in order to obtain precise human dimensional data including waist circumference and hip circumference
BIA Bioelectrical Impedance Analysis
The TANITA device TANITA- mc980 provides individual weight measurements for the right arm left arm trunk right leg and left leg Additionally it generates a comprehensive body composition report that includes body weight BW percentage of body fat fat body fat mass FM BMI and fat-free mass FFM
DXA Dual-energy X-ray Absorptiometry
During DXA measurements Horizon Hologic all volunteers will be required to wear uniform disposable lab coats and remove any metal accessories Dual-energy X-ray absorptiometry DXA utilizes a low dose X-ray beam with two energy peaks one predominantly absorbed by soft tissues and the other mainly absorbed by bone to assess the whole body at the workbench This enables quick differentiation of bone fraction from total body composition and provides penetration analysis of soft tissue through software algorithms for accurate determination of fat mass and fat-free mass
BODPOD Air Displacement Plethysmography
Prior to the test the volunteers underwent a fasting period and refrained from engaging in exercise intense physical activity or smoking within two hours To minimize any potential impact on measurement results it was required for them to wear a well-fitting swimsuit boxers for men one-piece bathing suit for women a swimming cap and remove all accessories such as watches necklaces earrings rings and socks from their bodies BODPOD GS-X Cosmed operates on the principle of air displacement similar to the classical underwater weighing method Utilizing a 2-component model approach based on body composition analysis divides it into two components body fat and free fat mass By measuring gas volume displaced and considering differences in density between fat and non-fat tissues along with volunteers body weight data upon entering the test chamber allows calculation of both percentage of body fat and percentage of lost body fat
MRI Magnetic Resonance Imaging
This experiment used cutting-edge magnetic resonance imaging MRI United-Imaging Healthcare uMR790 instrument measurement no injection of contrast medium volunteers lie flat on the MRI bed body using a newly developed rapid magnetic resonance dynamic imaging sequence to scan the whole body covering the neck to the knee MRI scanning by trained professionals All subjects will undergo the test and the data collected will be used to assist in the development of computer language programming for whole-body fat quantification and segmentation
Deuterium dilution technology
Over the past 50 years stable isotope technology has been extensively utilized in the field of human nutrition Deuterium a stable and nonradioactive isotope of hydrogen is employed in the form of deuterium oxide which is orally administered to volunteers and thoroughly mixed with their body water Subsequently it is excreted through urine saliva sweat and milk The recycling process of deuterium oxide within the body mirrors that of regular water as it becomes dispersed throughout the body and eventually expelled This technique can be applied to both adults and children moreover by providing lactating mothers with deuterium oxide water intake data can be obtained regarding breast milk consumption by breastfed infants Prior to administering water baseline urine samples were collected from adult participants who then received 30g of precisely measured deuterated oxide water with an accuracy up to 0001g Three hours later additional urine samples were collected for analysis purposes By examining changes in deuterium abundance within these samples calculations can be made regarding total body water content while fat weight can be determined using the formula FFMkg TBW kg0732
Body composition will be measured by the following methods
The fasting body weight and height were measured using the Seca medical metric system Seca 311231 Germany Volunteers were instructed to wear a standardized disposable lab coat and stand barefoot on an electronic scale for accurate measurements Barefoot height was measured to the nearest millimeter using a commercially available Leicester stadiometer Seca 217 Germany Volunteers were positioned in the center of the 3D scanning room Scanatic 360 and instructed to maintain proper posture while our scanning staff operated the scanner sensor and camera in order to obtain precise human dimensional data including waist circumference and hip circumference
BIA Bioelectrical Impedance Analysis
The TANITA device TANITA- mc980 provides individual weight measurements for the right arm left arm trunk right leg and left leg Additionally it generates a comprehensive body composition report that includes body weight BW percentage of body fat fat body fat mass FM BMI and fat-free mass FFM
DXA Dual-energy X-ray Absorptiometry
During DXA measurements Horizon Hologic all volunteers will be required to wear uniform disposable lab coats and remove any metal accessories Dual-energy X-ray absorptiometry DXA utilizes a low dose X-ray beam with two energy peaks one predominantly absorbed by soft tissues and the other mainly absorbed by bone to assess the whole body at the workbench This enables quick differentiation of bone fraction from total body composition and provides penetration analysis of soft tissue through software algorithms for accurate determination of fat mass and fat-free mass
BODPOD Air Displacement Plethysmography
Prior to the test the volunteers underwent a fasting period and refrained from engaging in exercise intense physical activity or smoking within two hours To minimize any potential impact on measurement results it was required for them to wear a well-fitting swimsuit boxers for men one-piece bathing suit for women a swimming cap and remove all accessories such as watches necklaces earrings rings and socks from their bodies BODPOD GS-X Cosmed operates on the principle of air displacement similar to the classical underwater weighing method Utilizing a 2-component model approach based on body composition analysis divides it into two components body fat and free fat mass By measuring gas volume displaced and considering differences in density between fat and non-fat tissues along with volunteers body weight data upon entering the test chamber allows calculation of both percentage of body fat and percentage of lost body fat
MRI Magnetic Resonance Imaging
This experiment used cutting-edge magnetic resonance imaging MRI United-Imaging Healthcare uMR790 instrument measurement no injection of contrast medium volunteers lie flat on the MRI bed body using a newly developed rapid magnetic resonance dynamic imaging sequence to scan the whole body covering the neck to the knee MRI scanning by trained professionals All subjects will undergo the test and the data collected will be used to assist in the development of computer language programming for whole-body fat quantification and segmentation
Deuterium dilution technology
Over the past 50 years stable isotope technology has been extensively utilized in the field of human nutrition Deuterium a stable and nonradioactive isotope of hydrogen is employed in the form of deuterium oxide which is orally administered to volunteers and thoroughly mixed with their body water Subsequently it is excreted through urine saliva sweat and milk The recycling process of deuterium oxide within the body mirrors that of regular water as it becomes dispersed throughout the body and eventually expelled This technique can be applied to both adults and children moreover by providing lactating mothers with deuterium oxide water intake data can be obtained regarding breast milk consumption by breastfed infants Prior to administering water baseline urine samples were collected from adult participants who then received 30g of precisely measured deuterated oxide water with an accuracy up to 0001g Three hours later additional urine samples were collected for analysis purposes By examining changes in deuterium abundance within these samples calculations can be made regarding total body water content while fat weight can be determined using the formula FFMkg TBW kg0732
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