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

May 15, 2022 updated by: Dr Oonagh Markey, Loughborough University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Loughborough, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Apparently healthy, recreationally active adults.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lean Individuals
waist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2
Other: No intervention
There is no intervention in this study
Obese Individuals
waist circumference ≥102cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2
Other: No intervention
There is no intervention in this study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Cross-sectional (all outcome measures will be collected within a 2 week period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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)
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
Cross-sectional (all outcome measures will be collected within a 2 week period)
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
Cross-sectional (all outcome measures will be collected within a 2 week period)
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
Cross-sectional (all outcome measures will be collected within a 2 week period)
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
Cross-sectional (all outcome measures will be collected within a 2 week period)
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
Cross-sectional (all outcome measures will be collected within a 2 week period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loughborough University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oonagh Markey, BSc, PhD, Vice-Chancellor's Research Fellow, Loughborough University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R19-P144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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