Cross Validation of Body Composition Measurement

NCT06453564 | Enrolling By Invitation

• 1 other identifier: SIAT-IRB-221115-H0630
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Body Composition

Outcome Measures

Primary Outcomes (8)

• Weight

  Weight in kilograms will be measured by scale (Seca 311231, Germany), DXA (Dual-energy X-ray Absorptiometry), TANITA, BODPOD (Air Displacement Plethysmography).

  About 10 minutes.

• Height

  Height in centimetres will be measured by Leicester stadiometer(Seca 217, Germany).

  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).

  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.

  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.

  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).

  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.

  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).

  About a week.

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Healthy volunteers
• BMI ranges between 18-35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• John R. Speakman: lead

Study Sites (1)

Shenzhen Institutes of advanced technology

Shenzhen, Guangdong, China

Location

Related Publications (2)

• 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.

  PMID: 33665639 BACKGROUND

• WEIR 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.

  PMID: 15394301 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: June 11, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CN (1)