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临床试验/NCT02658539
NCT02658539已完成不适用

Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

University of Reading1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2016年2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
370
试验地点
1
主要终点
Total body composition

研究概览

简要总结

Research has shown that body composition is a key component of health and future disease risk. Being overweight and obese is associated with a higher body fat composition, and a greater risk of developing type II diabetes and heart disease. The location where fat is stored in the body is becoming increasingly recognised an important predictor of risk, with extra fat around the abdomen and waist (referred to as the android pattern of fat distribution or 'apple' shape) thought to increase your disease risk than storing fat around the thighs and buttocks (gynoid pattern of fat distribution or 'pear' shape). As a result, there is significant interest in techniques to accurately monitor and detect changes in body composition, and also physiological and lifestyle factors which influence body fat, lean tissue mass and bone mineral density. This cross sectional human study will look at how physiological, behavioural and genetic factors relate to total body composition in 1,196 healthy men and women aged between 18 and 70 years. Interested applicants will be invited to attend for a single visit at the Hugh Sinclair Unit of Human Nutrition at the University of Reading. This visit lasts around two hours and includes noninvasive measures of body composition (bio-electrical impedance and dual energy x-ray absorptiometry), arterial stiffness and fasting measures of metabolic health. Diet and physical activity will then be monitored over a four day period using diet and activity diaries, and an activity monitor. The findings from this study will contribute to the evidence base on how subject characteristics influence body composition and inform on the design of future human studies on body composition methodology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 18.5-39.9 kg/m2
  • Not having suffered a myocardial infarction/stroke in the past 12 months
  • Not hyperlipidaemic (total cholesterol level < 7.8 mmol/l and triacylglycerol < 2.3 mmol/l).
  • Not diabetic (diagnosed as fasting blood glucose > 7 mmol/l) or suffer from other endocrine disorders
  • Not suffering from renal or bowel disease or have a history of cholestatic liver disease or pancreatitis
  • Not diagnosed with cancer
  • Not suffering from arthritis or fracture deformity of the spine or femur
  • Not undergone bone related surgeries such as hip replacement or fusion(s)
  • Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
  • No history of alcohol abuse
  • Not anaemic (Haemoglobin >115 g/l for women and 125 g/l for men)

排除标准

  • Due to the use of ionising radiation by the dual energy x-ray absorptiometry (DXA) scanner to assess total body composition and bone mineral density, the following exclusion criteria apply:
  • Females who are breastfeeding, may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions.
  • Individuals with other radio-opaque implants (such as a knee or other joint replacement) or medical devices (such as a pacemaker).

结局指标

主要结局

Total body composition

时间窗: 1 year

Measured using dual-energy x-ray absorptiometry

次要结局

  • Body composition(1 year)
  • Arterial stiffness(1 year)
  • Fasting blood lipids(1 year)
  • Markers of insulin resistance(1 year)
  • Dietary intake(1 year)
  • Blood pressure(1 year)
  • Anthropometric measurements(1 year)
  • C-reactive protein(1 year)
  • Physical activity(1 year)

研究者

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

Julie Lovegrove

Prof BSc Diet (Dip) PhD RNutr FAfN

University of Reading

研究点 (1)

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