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NCT Number: NCT02658539

Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

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.

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Key information

Conditions

Body Composition, Beneficial Glucocorticoid Receptor Deficiency

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Not anaemic (Haemoglobin >115 g/l for women and 125 g/l for men)

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).

Treatment and study plan

Primary outcomes

  1. Total body composition

    Time frame: 1 year

    Measured using dual-energy x-ray absorptiometry

Secondary outcomes

  1. Body composition

    Time frame: 1 year

    Assessed using bio-electrical impedance

  2. Fasting blood lipids

    Time frame: 1 year

    Total cholesterol, triacylglycerol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and non-esterified fatty acids

  3. Markers of insulin resistance

    Time frame: 1 year

    Glucose, insulin and indices of insulin resistance/sensitivity

  4. Arterial stiffness

    Time frame: 1 year

    Stiffness index and Reflection index measured using digital volume pulse and Mobil-O-Graph

  5. Blood pressure

    Time frame: 1 year

    Systolic and diastolic blood pressure

  6. C-reactive protein

    Time frame: 1 year

    Measured using a clinical chemistry analyser

  7. Dietary intake

    Time frame: 1 year

    Assessed using a 4-day weighed intake

  8. Physical activity

    Time frame: 1 year

    Assessed over 4 days using an accelerometer and activity diary

  9. Anthropometric measurements

    Time frame: 1 year

    Body mass index, waist circumference and hip circumference

Other outcomes

  1. Genotyping

    Time frame: 1 year

    Single nucleotide polymorphisms in genes associated with body composition

  2. Vitamin D status (25 hydroxy vitamin D)

    Time frame: 1 year

    Assessed using HPLC or GC-MS

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Acronym: BODYCON

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2016
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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