- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712579
Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SFA-Rich Meal
Participants will consume a SFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected
|
Saturated fatty acid-rich test meal, containing 75g test fat
|
Experimental: MUFA-Rich Meal
Participants will consume a MUFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected
|
Monounsaturated fatty acid-rich test meal, containing 75g test fat
|
What is the study measuring?
Primary Outcome Measures
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 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
|
White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
This will be assessed following the collection of blood samples
|
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
|
This will be assessed following the collection of white adipose tissue samples
|
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
|
Assessed following the collection of blood samples
|
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
|
Assessed following the collection of blood samples
|
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
|
Assessed following the collection of blood samples
|
Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R18-P124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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