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临床试验/NCT02118675
NCT02118675已完成不适用

Tanita® BIA System Validation

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
The Primary purpose is to measure children and adult body composition data using different methods - bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical).

研究概览

简要总结

The study is to collect the body composition data using five different methods-bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical), deuterium dilution (heavy water), body circumferences (tape measure, TC2), and tissue thickness by ultrasound (GE Medical, BodyMetrix).

详细描述

If you are eligible and you choose to participate in this study, you will be asked to come to the Pennington Biomedical Research Center in Baton Rouge between 7:00 and 11:00am after a 10-hour fast (nothing to eat or drink besides water for 10 hours prior to your appointment). The study visit will take approximately five hours. During the visit, you will complete the informed consent process and then complete several body measurements and body composition procedures immediately afterwards.

Description of study procedures

Body Measurements (about 10 minutes):

A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements. Your BMI will be calculated from these measurements.

Body Composition and Circumference Measurements Deuterium Dilution (heavy water) This test is to measure the amount of water in your body. After a fasting urine sample is collected, you will drink a glass of water that has been enriched with an atom called a stable isotope (deuterium). After you drink this non-radioactive heavy water, you will provide urine samples several times over the next 4 hours.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being either male or female
  • Being from 5 to 80 years of age
  • Being considered normal weight, overweight, or obese based on specified BMI ranges
  • Having a bodyweight of less than 440 pounds
  • Being willing to comply with the study procedures

排除标准

  • Having metal-containing objects in your body
  • Being pregnant or attempting to become pregnant
  • Being claustrophobic
  • Having medical implants such as a pacemaker or metal joint replacements
  • Being a professional athlete or someone with severe oedema or dehydration
  • Having a body weight greater than 440 pounds

结局指标

主要结局

The Primary purpose is to measure children and adult body composition data using different methods - bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical).

时间窗: One five hour visit (Baseline)

Tanita® has several Bioelectrical Impedance Analysis (BIA) systems on the market. BIA is considered one of the most reliable and accessible methods of screening body fat. This study will collect data from the Tanita® systems, DXA, BodPod, and total body water to further improve the accuracy of Tanita® products for adults and children.

次要结局

  • The secondary outcome measure it to improve the BIA body composition using deuterium dilution (heavy water), body circumferences (tape measure, TC2, Human Solutions), and tissue thickness by ultrasound (GE Medical, BodyMetrix).(One five hour visit (Baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Heymsfield

Principal Investigator

Pennington Biomedical Research Center

研究点 (1)

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