InflammationNCT04078776
Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals
An observational study of Inflammation and Obesity, run by Loughborough University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity, Inflammatory Response
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2019to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Apparently healthy, recreationally active adults.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- No intervention
- Medical subject headings
- Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Lean Individuals | waist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2 Receives: Other: No intervention | |
| Obese Individuals | waist circumference ≥102cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
This will be assessed following the collection of fasted white adipose tissue
Measured: 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
This will be assessed following the collection of fasted white adipose tissue
Measured: 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)
This will be assessed following the collection of fasted blood samples
Measured: Cross-sectional (all outcome measures will be collected within a 2 week period)
Habitual Dietary Intake
This will be assessed following the collection of a 4 day weighed food diary
Measured: Cross-sectional (all outcome measures will be collected within a 2 week period)
Physical Activity
Assessed using Actigraph accelerometers over a 4 day period
Measured: 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)
This will be assessed following the collection of fasted blood samples
Measured: 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)
This will be assessed following the collection of fasted blood samples
Measured: Cross-sectional (all outcome measures will be collected within a 2 week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start25 Oct 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oonagh Markey, Loughborough University
- Investigators
- Oonagh Markey, BSc, PhD, Principal investigator, Vice-Chancellor's Research Fellow, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078776
- Sponsor's protocol ID
- R19-P144
- Status last verified
- May 2022
- First submitted
- 2 Sep 2019
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals
- ClinicalTrials.gov ID
- NCT04078776
- Acronym / sponsor ID
- R19-P144
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean Individuals | – | Other: No interventionwaist circumference ≤94 cm (men) and 80 cm (women) and BMI ≥ 21.0 kg/m2 |
| Obese Individuals | – | Other: No interventionwaist circumference ≥102cm (men) and 88 cm (women) and BMI ≥ 30.0kg/m2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Apparently healthy, recreationally active adults.
Key inclusion criteria (6 listed)
- 18-40 years
- Waist circumference/BMI criteria:
- Recreationally active (> 3 x 30 min moderate exercise per week)
- Blood pressure systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention in this study | Other | Lean Individuals, Obese Individuals |
Primary outcome
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
7 secondary outcomes
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)
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)
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)
Habitual Dietary Intake
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oonagh Markey, BSc, PhD principal investigator
Vice-Chancellor's Research Fellow, Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Obesity, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.