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

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ClinicalTrials.gov Identifier: NCT02658539
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

Study Description
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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.

Condition or disease
Body Composition, Beneficial

Study Design
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Study Type : Observational
Actual Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
Study Start Date : February 2016
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Total body composition [ Time Frame: 1 year ]
    Measured using dual-energy x-ray absorptiometry


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA

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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men and women living in and around Reading, Berkshire, United Kingdom
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658539


Locations
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United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Julie A Lovegrove, BSc PhD University of Reading
More Information
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Responsible Party: Julie Lovegrove, Prof BSc Diet (Dip) PhD RNutr FAfN, University of Reading
ClinicalTrials.gov Identifier: NCT02658539    
Other Study ID Numbers: 13/55
14/SC/1095 ( Other Identifier: NHS Research Ethics Committee )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Keywords provided by Julie Lovegrove, University of Reading:
Body fat distribution
Bone mineral density
Dual-energy x-ray absorptiometry