Clinical trial NCT04078776: Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals
Official title: Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Obesity
Inflammatory Response
Cardiovascular Risk Factor
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Apparently healthy, recreationally active adults.

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.


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

Primary outcomes:
measure: 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)
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary outcomes:
measure: Systemic Markers of Inflammation (for example C-reactive protein and interleukin 6 concentrations, determined by spectrophotometric assay/ ELISA)
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
measure: Gene expression of key markers of metabolic inflammation in white adipose tissue
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
measure: Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
measure: Habitual Dietary Intake
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
measure: Physical Activity
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
measure: Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
measure: Fasting Serum Lipid Profile (for example total cholesterol, HDL cholesterol and triacylglycerol concentrations, measured using a spectrophotometric assay)
timeFrame: Cross-sectional (all outcome measures will be collected within a 2 week period)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
Study officials:
affiliation: Vice-Chancellor's Research Fellow, Loughborough University
name: Oonagh Markey, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: