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Clinical Trials/NCT04078776
NCT04078776
Completed
Not Applicable

Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals

Loughborough University1 site in 1 country12 target enrollmentOctober 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammation
Sponsor
Loughborough University
Enrollment
12
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2019
End Date
August 1, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Oonagh Markey

Vice-Chancellor's Research Fellow

Loughborough University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)(Cross-sectional (all outcome measures will be collected within a 2 week period))
  • Habitual Dietary Intake(Cross-sectional (all outcome measures will be collected within a 2 week period))
  • Systemic Markers of Inflammation (for example C-reactive protein and interleukin 6 concentrations, determined by spectrophotometric assay/ ELISA)(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(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)(Cross-sectional (all outcome measures will be collected within a 2 week period))
  • Physical Activity(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)(Cross-sectional (all outcome measures will be collected within a 2 week period))

Study Sites (1)

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