- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078776
Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals
This study will compare the systemic and white adipose tissue inflammatory profile of individuals who are classified as lean and obese. Blood and white adipose tissue samples will be collected in the fasted state to assess inflammatory status.
There is evidence to suggest that markers of inflammation in the blood and white adipose tissue increase with increasing levels of obesity. However, the white adipose tissue total protein content and phosphorylation of proteins involved in inflammatory pathways has not previously been compared between lean and obese individuals.
The investigators hypothesise that obese individuals will have increased levels of inflammation in the blood and white adipose tissue, compared to their lean counterparts.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Loughborough, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-40 years
Waist circumference/BMI criteria:
- Lean participants: waist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2 or
- Obese participants: waist circumference ≥102 cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2
- Recreationally active (> 3 x 30 min moderate exercise per week)
- Blood pressure systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
Exclusion Criteria:
- Smoker (including vaping)
- Cardiometabolic or inflammatory disease (e.g. heart disease, high blood pressure, type 2 diabetes)
- Taking medication or nutritional supplements (e.g. fish oil/prebiotics) known to interfere with study outcomes (including inflammation, immune function or lipid/carbohydrate metabolism) or prescribed antibiotics within the last 3 months
- Unstable weight history (≥ 3kg loss or gain in previous 3 months)
- An allergy to lidocaine (determined by the Schools standard health questionnaire)
- Parallel participation in another intervention study
- Women who are pregnant or lactating
- Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a metabolic study
- Alcohol consumption >28 units per week for a man or >21 units per week for a woman
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lean Individuals
waist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2
|
There is no intervention in this study
|
|
Obese Individuals
waist circumference ≥102cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2
|
There is no intervention in this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protein expression (content and phosphorylation) of key markers of metabolic inflammation in white adipose tissue (for example assessment of Nuclear factor kappa B (NFKB) total protein and phosphorylation by western blot analysis)
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of fasted white adipose tissue samples
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systemic Markers of Inflammation (for example C-reactive protein and interleukin 6 concentrations, determined by spectrophotometric assay/ ELISA)
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of fasted white adipose tissue
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
|
Gene expression of key markers of metabolic inflammation in white adipose tissue
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of fasted white adipose tissue
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
|
Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of fasted blood samples
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
|
Habitual Dietary Intake
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of a 4 day weighed food diary
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
|
Physical Activity
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
Assessed using Actigraph accelerometers over a 4 day period
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
|
Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of fasted blood samples
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
|
Fasting Serum Lipid Profile (for example total cholesterol, HDL cholesterol and triacylglycerol concentrations, measured using a spectrophotometric assay)
Time Frame: Cross-sectional (all outcome measures will be collected within a 2 week period)
|
This will be assessed following the collection of fasted blood samples
|
Cross-sectional (all outcome measures will be collected within a 2 week period)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oonagh Markey, BSc, PhD, Vice-Chancellor's Research Fellow, Loughborough University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R19-P144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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