Body Composition, BeneficialBODYCONNCT02658539
Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
An observational study of Body Composition, Beneficial, run by University of Reading at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Beneficial
- How many people
- 370 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women living in and around Reading, Berkshire, United Kingdom
Who may be able to join
- 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
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- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
About this study
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
- Keywords
- Body fat distribution, Bone mineral density, Dual-energy x-ray absorptiometry
- Medical subject headings
- Glucocorticoid Receptor Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body composition
Measured using dual-energy x-ray absorptiometry
Measured: 1 year
Secondary outcomes (9)
Body composition
Assessed using bio-electrical impedance
Measured: 1 year
Fasting blood lipids
Total cholesterol, triacylglycerol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and non-esterified fatty acids
Measured: 1 year
Markers of insulin resistance
Glucose, insulin and indices of insulin resistance/sensitivity
Measured: 1 year
Arterial stiffness
Stiffness index and Reflection index measured using digital volume pulse and Mobil-O-Graph
Measured: 1 year
Blood pressure
Systolic and diastolic blood pressure
Measured: 1 year
C-reactive protein
Measured using a clinical chemistry analyser
Measured: 1 year
Dietary intake
Assessed using a 4-day weighed intake
Measured: 1 year
Physical activity
Assessed over 4 days using an accelerometer and activity diary
Measured: 1 year
Anthropometric measurements
Body mass index, waist circumference and hip circumference
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Composition, BeneficialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, BSc PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658539
- Sponsor's protocol ID
- 13/55
- Other IDs
- 14/SC/1095
- Acronym
- BODYCON
- Status last verified
- Oct 2019
- First submitted
- 8 Jan 2016
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35241101
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
- ClinicalTrials.gov ID
- NCT02658539
- Acronym / sponsor ID
- BODYCON / 13/55
- Conditions
- Body Composition, Beneficial
- Keywords
- Body fat distribution, Bone mineral density, Dual-energy x-ray absorptiometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women living in and around Reading, Berkshire, United Kingdom
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total body composition
Time frame: 1 year
Measured using dual-energy x-ray absorptiometry
9 secondary outcomes
Body composition
Time frame: 1 year
Fasting blood lipids
Time frame: 1 year
Markers of insulin resistance
Time frame: 1 year
Arterial stiffness
Time frame: 1 year
Blood pressure
Time frame: 1 year
C-reactive protein
Time frame: 1 year
Dietary intake
Time frame: 1 year
Physical activity
Time frame: 1 year
Anthropometric measurements
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Derived from this study: PubMed 35241101Ozen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Lovegrove, BSc PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition, Beneficial, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body composition (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.