Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
BODYCON
2 other identifiers
observational
370
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedOctober 10, 2019
October 1, 2019
3.7 years
January 8, 2016
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total body composition
Measured using dual-energy x-ray absorptiometry
1 year
Secondary Outcomes (9)
Body composition
1 year
Fasting blood lipids
1 year
Markers of insulin resistance
1 year
Arterial stiffness
1 year
Blood pressure
1 year
- +4 more secondary outcomes
Other Outcomes (2)
Genotyping
1 year
Vitamin D status (25 hydroxy vitamin D)
1 year
Eligibility Criteria
Men and women living in and around Reading, Berkshire, United Kingdom
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP, United Kingdom
Related Publications (1)
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.
PMID: 35241101DERIVED
Biospecimen
A fasting blood sample will be taken at the end of the study visit for the measurement of fasting lipids (total and high density lipoprotein-cholesterol, triacylglycerol and non-esterified fatty acids), glucose, insulin, C-reactive protein and for vitamin D status. The buffy coat (consisting of white blood cells) will be isolated from the blood sample for genotyping analysis.
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Julie A Lovegrove, BSc PhD
University of Reading
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof BSc Diet (Dip) PhD RNutr FAfN
Study Record Dates
First Submitted
January 8, 2016
First Posted
January 20, 2016
Study Start
February 1, 2016
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
October 10, 2019
Record last verified: 2019-10