Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

NCT ID: NCT02658539

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 370 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-09-30

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.

Conditions

Body Composition, Beneficial

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Julie Lovegrove

Prof BSc Diet (Dip) PhD RNutr FAfN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie A Lovegrove, BSc PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35241101 (View on PubMed)

Other Identifiers

14/SC/1095

Identifier Type: OTHER

Identifier Source: secondary_id

13/55

Identifier Type: -

Identifier Source: org_study_id