InflammationNCT03712579
Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses
A study testing SFA-Rich Meal and MUFA-Rich Meal in people with Inflammation and Obesity, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Cardiometabolic disorders are a leading cause of death worldwide. Replacing saturated fatty acids (SFA) with unsaturated fatty acids is recommended as a way of lowering cardiometabolic disease risk. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity, Inflammatory Response
- What is being tested?
- SFA-Rich Meal and MUFA-Rich Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2019to 15 Oct 2020
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years
- BMI = 25-40 kg/m2
- Male or Female
- Waist circumference >94 cm (men) and >80cm (women)*
- Physically active (> 3 x 30 min moderate intensity exercise per week)
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- No cardiometabolic (e.g. heart disease, high blood pressure, type 2 diabetes) or inflammatory illness
- NOTE: If waist circumference falls below 94 cm for men or 80cm for women but BMI is >25 kg/m2 volunteers may still be recruited at the PI's discretion.
Who cannot join
- Smoker
- Previous diagnosis of anaemia
- Women who are pregnant or lactating
- Taking medication known to interfere with study outcomes (e.g. treatment for hyperlidaemia, hypertension, inflammation or hypercoagulation) or prescribed antibiotics within the last 3 months
- Taking nutritional supplements known to interfere with study outcomes (e.g. fish oil or evening primrose oil)
- Unstable weight history (>3 kg loss or gain in the previous 3 months)
Show all 11Show fewer
- An allergy to lidocaine
- Those with known or suspected food intolerances, allergies or hypersensitivity to any components of the meal (e.g. lactose/wheat intolerance)
- Alcohol consumption >28 units per week for a man or >21 units per week for a woman
- Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
- Parallel participation in another intervention study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses: a Randomized Controlled Postprandial Study
Cardiometabolic disorders are a leading cause of death worldwide. Replacing saturated fatty acids (SFA) with unsaturated fatty acids is recommended as a way of lowering cardiometabolic disease risk.
Consuming a diet rich in SFA may lead to a greater metabolic-inflammatory response in white adipose tissue during the fasting state, when compared to eating a diet rich in monounsaturated fatty acids (MUFA). Since individuals spend most of the day in the fed (or postprandial) state, it is important to see how different types of dietary fatty acids affect postprandial white adipose tissue and systemic metabolic-inflammatory responses.
This study will investigate the effect of a SFA-rich meal on markers of white adipose tissue and systemic metabolic-inflammation, compared to a MUFA-rich meal in overweight adults. In a randomised, single blind controlled, cross-over manner participants will consume either a SFA- or MUFA-rich meal and sequential blood and white adipose tissue samples will be collected before and until 6 hours postprandially.
- Being tested
- SFA-Rich Meal, MUFA-Rich Meal
- Medical subject headings
- Inflammation, Obesity, Cardiovascular Diseases, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFA-Rich MealDietary supplement
Saturated fatty acid-rich test meal, containing 75g test fat
MUFA-Rich MealDietary supplement
Monounsaturated fatty acid-rich test meal, containing 75g test fat
| Study group | Role | What they receive |
|---|---|---|
| SFA-Rich Meal | Experimental | Participants will consume a SFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected Receives: Dietary Supplement: SFA-Rich Meal |
| MUFA-Rich Meal | Experimental | Participants will consume a MUFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected Receives: Dietary Supplement: MUFA-Rich Meal |
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 NFKB/IKBa total protein and phosphorylation by western blot analysis)
This will be assessed following the collection of white adipose tissue samples across the postprandial period
Measured: White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
Secondary outcomes (5)
Systemic Markers of Inflammation (for example TNFa and IL-6 concentrations, determined using an ELISA)
This will be assessed following the collection of blood samples
Measured: Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Gene expression of key markers of metabolic inflammation in white adipose tissue
This will be assessed following the collection of white adipose tissue samples
Measured: White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)
Assessed following the collection of blood samples
Measured: Blood samples will be collected at -0.5 (fasted) and 4 hours postprandially
Serum Markers of Insulin Resistance
Assessed following the collection of blood samples
Measured: Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Serum Lipid Profile (primarily triacylglycerol and non-esterified fatty acid concentrations, measured using a spectrophotometric assay)
Assessed following the collection of blood samples
Measured: Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start21 Jan 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 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, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712579
- Sponsor's protocol ID
- R18-P124
- Status last verified
- May 2022
- First submitted
- 6 Jun 2018
- 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
- Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses: a Randomized Controlled Postprandial Study
- ClinicalTrials.gov ID
- NCT03712579
- Acronym / sponsor ID
- R18-P124
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 19 Oct 2018 (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.
Cardiometabolic disorders are a leading cause of death worldwide. Replacing saturated fatty acids (SFA) with unsaturated fatty acids is recommended as a way of lowering cardiometabolic disease risk.
Consuming a diet rich in SFA may lead to a greater metabolic-inflammatory response in white adipose tissue during the fasting state, when compared to eating a diet rich in monounsaturated fatty acids (MUFA). Since individuals spend most of the day in the fed (or postprandial) state, it is important to see how different types of dietary fatty acids affect postprandial white adipose tissue and systemic metabolic-inflammatory responses.
This study will investigate the effect of a SFA-rich meal on markers of white adipose tissue and systemic metabolic-inflammation, compared to a MUFA-rich meal in overweight adults. In a randomised, single blind controlled, cross-over manner participants will consume either a SFA- or MUFA-rich meal and sequential blood and white adipose tissue samples will be collected before and until 6 hours postprandially.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFA-Rich Meal | Experimental | Dietary Supplement: SFA-Rich MealParticipants will consume a SFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected |
| MUFA-Rich Meal | Experimental | Dietary Supplement: MUFA-Rich MealParticipants will consume a MUFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-50 years
- BMI = 25-40 kg/m2
- Male or Female
- Waist circumference >94 cm (men) and >80cm (women)*
- Physically active (> 3 x 30 min moderate intensity exercise per week)
Key exclusion criteria (11 listed)
- Smoker
- Previous diagnosis of anaemia
- Women who are pregnant or lactating
- Taking medication known to interfere with study outcomes (e.g. treatment for hyperlidaemia, hypertension, inflammation or hypercoagulation) or prescribed antibiotics within the last 3 months
- Taking nutritional supplements known to interfere with study outcomes (e.g. fish oil or evening primrose oil)
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 |
|---|---|---|
| SFA-Rich MealSaturated fatty acid-rich test meal, containing 75g test fat | Dietary supplement | SFA-Rich Meal |
| MUFA-Rich MealMonounsaturated fatty acid-rich test meal, containing 75g test fat | Dietary supplement | MUFA-Rich Meal |
Primary outcome
Protein expression (content and phosphorylation) of key markers of metabolic inflammation in white adipose tissue (for example assessment of NFKB/IKBa total protein and phosphorylation by western blot analysis)
Time frame: White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
This will be assessed following the collection of white adipose tissue samples across the postprandial period
5 secondary outcomes
Systemic Markers of Inflammation (for example TNFa and IL-6 concentrations, determined using an ELISA)
Time frame: Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Gene expression of key markers of metabolic inflammation in white adipose tissue
Time frame: White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)
Time frame: Blood samples will be collected at -0.5 (fasted) and 4 hours postprandially
Serum Markers of Insulin Resistance
Time frame: Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Serum Lipid Profile (primarily triacylglycerol and non-esterified fatty acid concentrations, measured using a spectrophotometric assay)
Time frame: Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
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
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFA-Rich Meal and MUFA-Rich Meal in people with 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 8 inclusion and 11 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 NFKB/IKBa total protein and phosphorylation by western blot analysis) (time frame: White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially). 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.