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

NCT04078776 | Completed

• 1 other identifier: R19-P144
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Obesity; Inflammatory Response; Cardiovascular Risk Factor

Outcome Measures

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)

  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 Outcomes (7)

• 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)

• 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)

• Physical Activity

  Cross-sectional (all outcome measures will be collected within a 2 week period)

Study Arms (2)

Lean Individuals

waist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2

Other: No intervention

Obese Individuals

waist circumference ≥102cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2

Other: No intervention

Interventions

No intervention OTHER

There is no intervention in this study

Lean Individuals; Obese Individuals

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Apparently healthy, recreationally active adults.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Inflammation; Obesity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Oonagh Markey, BSc, PhD

  Vice-Chancellor's Research Fellow, Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chancellor's Research Fellow

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: October 25, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

GB (1)