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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 8, 2016
First Posted Date January 20, 2016
Last Update Posted Date October 10, 2019
Study Start Date February 2016
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
Total body composition [ Time Frame: 1 year ]
Measured using dual-energy x-ray absorptiometry
Original Primary Outcome Measures
 (submitted: January 14, 2016)
Total body composition measured using dual-energy x-ray absorptiometry [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures
 (submitted: November 1, 2018)
  • Body composition [ Time Frame: 1 year ]
    Assessed using bio-electrical impedance
  • Fasting blood lipids [ Time Frame: 1 year ]
    Total cholesterol, triacylglycerol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and non-esterified fatty acids
  • Markers of insulin resistance [ Time Frame: 1 year ]
    Glucose, insulin and indices of insulin resistance/sensitivity
  • Arterial stiffness [ Time Frame: 1 year ]
    Stiffness index and Reflection index measured using digital volume pulse and Mobil-O-Graph
  • Blood pressure [ Time Frame: 1 year ]
    Systolic and diastolic blood pressure
  • C-reactive protein [ Time Frame: 1 year ]
    Measured using a clinical chemistry analyser
  • Dietary intake [ Time Frame: 1 year ]
    Assessed using a 4-day weighed intake
  • Physical activity [ Time Frame: 1 year ]
    Assessed over 4 days using an accelerometer and activity diary
  • Anthropometric measurements [ Time Frame: 1 year ]
    Body mass index, waist circumference and hip circumference
Original Secondary Outcome Measures
 (submitted: January 14, 2016)
  • Body composition assessed using bio-electrical impedance [ Time Frame: 1 year ]
  • Fasting lipids (total cholesterol, triacylglycerol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and non-esterified fatty acids) [ Time Frame: 1 year ]
  • Markers of insulin resistance (glucose, insulin and indices of insulin resistance/sensitivity) [ Time Frame: 1 year ]
  • Arterial stiffness measured using digital volume pulse (stiffness index and reflection index) [ Time Frame: 1 year ]
  • Blood pressure (systolic and diastolic blood pressure) [ Time Frame: 1 year ]
  • C-reactive protein [ Time Frame: 1 year ]
  • Dietary intake assessed using a weighed food diary [ Time Frame: 1 year ]
  • Physical activity assessed using an accelerometer and activity diary [ Time Frame: 1 year ]
  • Anthropometric measurements (body mass index, waist circumference and hip circumference) [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2018)
  • Genotyping [ Time Frame: 1 year ]
    Single nucleotide polymorphisms in genes associated with body composition
  • Vitamin D status (25 hydroxy vitamin D) [ Time Frame: 1 year ]
    Assessed using HPLC or GC-MS
Original Other Pre-specified Outcome Measures
 (submitted: January 14, 2016)
  • Single nucleotide polymorphisms in genes associated with body composition [ Time Frame: 1 year ]
  • Vitamin D status (25 hydroxy vitamin D) [ Time Frame: 1 year ]
 
Descriptive Information
Brief Title Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
Official Title Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

Sampling Method Probability Sample
Study Population Men and women living in and around Reading, Berkshire, United Kingdom
Condition Body Composition, Beneficial
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 8, 2019)
370
Original Estimated Enrollment
 (submitted: January 14, 2016)
1196
Actual Study Completion Date September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02658539
Other Study ID Numbers 13/55
14/SC/1095 ( Other Identifier: NHS Research Ethics Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Julie Lovegrove, University of Reading
Study Sponsor University of Reading
Collaborators Not Provided
Investigators
Principal Investigator: Julie A Lovegrove, BSc PhD University of Reading
PRS Account University of Reading
Verification Date October 2019