Clinical trial NCT02658539: Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
Official title: Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition, Beneficial
Keywords: Body fat distribution
Bone mineral density
Dual-energy x-ray absorptiometry
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women living in and around Reading, Berkshire, United Kingdom

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.


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
* 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).

Primary outcomes:
measure: Total body composition
timeFrame: 1 year
Secondary outcomes:
measure: Body composition
timeFrame: 1 year
measure: Fasting blood lipids
timeFrame: 1 year
measure: Markers of insulin resistance
timeFrame: 1 year
measure: Arterial stiffness
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: C-reactive protein
timeFrame: 1 year
measure: Dietary intake
timeFrame: 1 year
measure: Physical activity
timeFrame: 1 year
measure: Anthropometric measurements
timeFrame: 1 year
Other outcomes:
measure: Genotyping
timeFrame: 1 year
measure: Vitamin D status (25 hydroxy vitamin D)
timeFrame: 1 year
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Julie A Lovegrove, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.