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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078776
• Other study ID #: R19-P144
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: May 2022
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Inflammation
• Inflammatory Response
• Obesity

Intervention

Other:
• No intervention
There is no intervention in this study

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systemic Markers of Inflammation (for example C-reactive protein and interleukin 6 concentrations, determined by spectrophotometric assay/ ELISA)	This will be assessed following the collection of fasted white adipose tissue	Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary	Gene expression of key markers of metabolic inflammation in white adipose tissue	This will be assessed following the collection of fasted white adipose tissue	Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary	Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)	This will be assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary	Habitual Dietary Intake	This will be assessed following the collection of a 4 day weighed food diary	Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary	Physical Activity	Assessed using Actigraph accelerometers over a 4 day period	Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary	Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)	This will be assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 2 week period)
Secondary	Fasting Serum Lipid Profile (for example total cholesterol, HDL cholesterol and triacylglycerol concentrations, measured using a spectrophotometric assay)	This will be assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 2 week period)