Skip to main content
Clinical Trials/NCT02658539
NCT02658539
Completed
N/A

Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

University of Reading1 site in 1 country370 target enrollmentFebruary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Body Composition, Beneficial
Sponsor
University of Reading
Enrollment
370
Locations
1
Primary Endpoint
Total body composition
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Lovegrove

Prof BSc Diet (Dip) PhD RNutr FAfN

University of Reading

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Total body composition

Time Frame: 1 year

Measured using dual-energy x-ray absorptiometry

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials