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Completed

NCT Number: 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.

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Key information

Conditions

Inflammation Body Weight Cardiovascular Risk Factor Inflammatory Response Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

There is no intervention in this study

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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