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

Completed

• Conditions: Obesity; Inflammation; Inflammatory Response; Cardiovascular Risk Factor
• Interventions: Other: No intervention

• Registration Number: NCT04078776
• Lead Sponsor: Loughborough University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Study Start: 2019-10-25
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese Individuals	No intervention	waist circumference ≥102cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2
Lean Individuals	No intervention	waist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
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)	This will be assessed following the collection of fasted blood samples
Habitual Dietary Intake	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
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)	This will be assessed following the collection of fasted white adipose tissue
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)	This will be assessed following the collection of fasted white adipose tissue
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)	This will be assessed following the collection of fasted blood samples
Physical Activity	Cross-sectional (all outcome measures will be collected within a 2 week period)	Assessed using Actigraph accelerometers over a 4 day 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)	This will be assessed following the collection of fasted blood samples

Trial Locations

Locations (1)

Loughborough University; 🇬🇧 Loughborough, United Kingdom