Body CompositionNCT06453564
Cross Validation of Body Composition Measurement
An observational study of Body Composition, run by John R. Speakman at 1 site in China.
Trial summary
Obesity, as a chronic disease, has emerged as one of the most pressing health concerns in the 21st century. According to statistics, over 2.1 billion individuals worldwide are affected by overweight or obesity. It is worth noting that obesity ranks fifth among the leading causes of mortality globally. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to 19 Jul 2026
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population was healthy. The women were not pregnant or planning to become pregnant and were lactating. None of the volunteers had metal implants in their bodies. All volunteers had no serious metabolic diseases that would affect the trial.
Who may be able to join
- Healthy volunteers
- BMI ranges between 18-35 kg/m2
Who cannot join
- current pregnancy or pregnancy within the last 12 months, and/or currently breast feeding or lactating
- Individuals with known non-communicable disease notably diabetes, cardiovascular disease or cancer
- any diseases or chronic use of medications that would influence ability to comply with the study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Obesity, as a chronic disease, has emerged as one of the most pressing health concerns in the 21st century. According to statistics, over 2.1 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.
Read the 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 volunteer's 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 0.001g). 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 FFM(kg) = TBW (kg)/0.732.
- Conditions
- Body Composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 18.5≤ BMI <23.9 | The investigators planned to recruit 10 volunteers with a BMI between 18 and 23. Half male, half female. There are no age restrictions. Because there are large differences in body composition among people with different BMI, there are also differences between men and women. The investigators will look at the differences in body composition measured by different methods for each individual in this group. | |
| 24≤BMI<27.9 | The investigators planned to recruit 10 volunteers with a BMI between 23 and 30. Half male, half female. There are no age restrictions. The volunteers in this group were relatively underweight. The investigators will look at the differences in body composition measured by different methods for each individual in this group. | |
| 28≤BMI<35 | The investigators planned to recruit 10 volunteers with a BMI between 30 and 35. Half male, half female. There are no age restrictions. The volunteers in this group were obese patients. The investigators will look at the differences in body composition measured by different methods for each individual in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight in kilograms will be measured by scale (Seca 311231, Germany), DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography).
Measured: About 10 minutes.
Height
Height in centimetres will be measured by Leicester stadiometer(Seca 217, Germany).
Measured: About 5 minutes.
BMI
BMI values in kg/m2 were calculated from weight measured by TANITA and height measured by Leicester stadiometer (Seca 217, Germany).
Measured: About 10 minutes (calculated).
Fat mass
Fat mass in kilograms will be measured by DXA (Dual-energy X-ray Absorptiometry), TANITA, MRI (United imaging uMR790 and BODPOD (Air Displacement Plethysmography). Total body fat in cubic centimeters will be converted to fat mass in kilograms using body density.
Measured: About two weeks (including the time to calculate the MIR results).
Fat free mass
Fat mass in kilograms will be measured by DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography) and deuterium dilution method.
Measured: About three weeks (including the sample analysis time taken by the deuterium dilution technique).
Fat%
Fat% will be measured by DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography) and MRI (United imaging uMR790).
Measured: About two weeks (including the time to calculate the MIR results).
Total body water
Total body water in kilograms will be measured by TANITA and deuterium dilution method.
Measured: About three weeks (including the sample analysis time taken by the deuterium dilution technique).
Total body volume
Total body volume in liters will be measured by BODPOD (Air Displacement Plethysmography) and MRI (United imaging uMR790).
Measured: About a week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start19 Jul 2024
- Primary completion19 Jul 2026 (estimated)
- Study completion19 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John R. Speakman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453564
- Sponsor's protocol ID
- SIAT-IRB-221115-H0630
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Speakman 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 33665639WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.
PubMed 15394301
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Validation of Body Composition Measurement
- ClinicalTrials.gov ID
- NCT06453564
- Acronym / sponsor ID
- SIAT-IRB-221115-H0630
- Conditions
- Body Composition
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- John R. SpeakmanUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 19 Jul 2026 (estimated)
- Study completion
- 19 Jul 2026 (estimated)
- First posted
- 11 Jun 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.
Obesity, as a chronic disease, has emerged as one of the most pressing health concerns in the 21st century. According to statistics, over 2.1 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 volunteer's 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 0.001g). 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 FFM(kg) = TBW (kg)/0.732.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18.5≤ BMI <23.9 | – | –The investigators planned to recruit 10 volunteers with a BMI between 18 and 23. Half male, half female. There are no age restrictions. Because there are large differences in body composition among people with different BMI, there are also differences between men and women. The investigators will look at the differences in body composition measured by different methods for each individual in this group. |
| 24≤BMI<27.9 | – | –The investigators planned to recruit 10 volunteers with a BMI between 23 and 30. Half male, half female. There are no age restrictions. The volunteers in this group were relatively underweight. The investigators will look at the differences in body composition measured by different methods for each individual in this group. |
| 28≤BMI<35 | – | –The investigators planned to recruit 10 volunteers with a BMI between 30 and 35. Half male, half female. There are no age restrictions. The volunteers in this group were obese patients. The investigators will look at the differences in body composition measured by different methods for each individual in this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was healthy. The women were not pregnant or planning to become pregnant and were lactating. None of the volunteers had metal implants in their bodies. All volunteers had no serious metabolic diseases that would affect the trial.
Key inclusion criteria (2 listed)
- Healthy volunteers
- BMI ranges between 18-35 kg/m2
Key exclusion criteria (3 listed)
- current pregnancy or pregnancy within the last 12 months, and/or currently breast feeding or lactating
- Individuals with known non-communicable disease notably diabetes, cardiovascular disease or cancer
- any diseases or chronic use of medications that would influence ability to comply with the study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight
Time frame: About 10 minutes.
Weight in kilograms will be measured by scale (Seca 311231, Germany), DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography).
Height
Time frame: About 5 minutes.
Height in centimetres will be measured by Leicester stadiometer(Seca 217, Germany).
BMI
Time frame: About 10 minutes (calculated).
BMI values in kg/m2 were calculated from weight measured by TANITA and height measured by Leicester stadiometer (Seca 217, Germany).
Fat mass
Time frame: About two weeks (including the time to calculate the MIR results).
Fat mass in kilograms will be measured by DXA (Dual-energy X-ray Absorptiometry), TANITA, MRI (United imaging uMR790 and BODPOD (Air Displacement Plethysmography). Total body fat in cubic centimeters will be converted to fat mass in kilograms using body density.
Fat free mass
Time frame: About three weeks (including the sample analysis time taken by the deuterium dilution technique).
Fat mass in kilograms will be measured by DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography) and deuterium dilution method.
Fat%
Time frame: About two weeks (including the time to calculate the MIR results).
Fat% will be measured by DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography) and MRI (United imaging uMR790).
Total body water
Time frame: About three weeks (including the sample analysis time taken by the deuterium dilution technique).
Total body water in kilograms will be measured by TANITA and deuterium dilution method.
Total body volume
Time frame: About a week.
Total body volume in liters will be measured by BODPOD (Air Displacement Plethysmography) and MRI (United imaging uMR790).
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 30 Mar 2025.
- Background: PubMed 33665639Speakman 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.
- Background: PubMed 15394301WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition, run by John R. Speakman 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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: About 10 minutes.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453564, which also lists 2 linked publications.
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 30 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.