Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

Completed

• Conditions: Body Composition, Beneficial

• Registration Number: NCT02658539
• Lead Sponsor: University of Reading

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-20
• Study Start: 2016-02
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total body composition	1 year	Measured using dual-energy x-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
Arterial stiffness	1 year	Stiffness index and Reflection index measured using digital volume pulse and Mobil-O-Graph
Body composition	1 year	Assessed using bio-electrical impedance
Fasting blood lipids	1 year	Total cholesterol, triacylglycerol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and non-esterified fatty acids
C-reactive protein	1 year	Measured using a clinical chemistry analyser
Markers of insulin resistance	1 year	Glucose, insulin and indices of insulin resistance/sensitivity
Dietary intake	1 year	Assessed using a 4-day weighed intake
Physical activity	1 year	Assessed over 4 days using an accelerometer and activity diary
Blood pressure	1 year	Systolic and diastolic blood pressure
Anthropometric measurements	1 year	Body mass index, waist circumference and hip circumference

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences, University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom