Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

Body Composition, Beneficial Clinical Trial

— BODYCON  

Official title:

Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658539
• Other study ID #: 13/55
• Secondary ID: 14/SC/1095
• Status: Completed
• Start date: February 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Body Composition, Beneficial

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genotyping	Single nucleotide polymorphisms in genes associated with body composition	1 year
Other	Vitamin D status (25 hydroxy vitamin D)	Assessed using HPLC or GC-MS	1 year
Primary	Total body composition	Measured using dual-energy x-ray absorptiometry	1 year
Secondary	Body composition	Assessed using bio-electrical impedance	1 year
Secondary	Fasting blood lipids	Total cholesterol, triacylglycerol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and non-esterified fatty acids	1 year
Secondary	Markers of insulin resistance	Glucose, insulin and indices of insulin resistance/sensitivity	1 year
Secondary	Arterial stiffness	Stiffness index and Reflection index measured using digital volume pulse and Mobil-O-Graph	1 year
Secondary	Blood pressure	Systolic and diastolic blood pressure	1 year
Secondary	C-reactive protein	Measured using a clinical chemistry analyser	1 year
Secondary	Dietary intake	Assessed using a 4-day weighed intake	1 year
Secondary	Physical activity	Assessed over 4 days using an accelerometer and activity diary	1 year
Secondary	Anthropometric measurements	Body mass index, waist circumference and hip circumference	1 year