Impact of Physiological, Lifestyle and Genetic Factors on Body Composition (BODYCON)

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.

Study Overview

• Status: Completed
• Conditions: Body Composition, Beneficial

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men and women living in and around Reading, Berkshire, United Kingdom

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body composition	Measured using dual-energy x-ray absorptiometry	1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genotyping	Single nucleotide polymorphisms in genes associated with body composition	1 year
Vitamin D status (25 hydroxy vitamin D)	Assessed using HPLC or GC-MS	1 year

Collaborators and Investigators

• Sponsor: University of Reading

Publications and helpful links

General Publications

• Ozen E, Mihaylova R, Weech M, Kinsella S, Lovegrove JA, Jackson KG. Association between dietary saturated fat with cardiovascular disease risk markers and body composition in healthy adults: findings from the cross-sectional BODYCON study. Nutr Metab (Lond). 2022 Mar 3;19(1):15. doi: 10.1186/s12986-022-00650-y.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Body fat distribution; Bone mineral density; Dual-energy x-ray absorptiometry
• Other Study ID Numbers: 13/55; 14/SC/1095 (Other Identifier: NHS Research Ethics Committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No