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Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses

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ClinicalTrials.gov Identifier: NCT03712579
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Oonagh Markey, Loughborough University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Inflammation Obesity Inflammatory Response Cardiovascular Diseases Overweight Dietary Supplement: SFA-Rich Meal Dietary Supplement: MUFA-Rich Meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses: a Randomized Controlled Postprandial Study
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

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
Dietary Supplement: SFA-Rich Meal
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
Dietary Supplement: MUFA-Rich Meal
Monounsaturated fatty acid-rich test meal, containing 75g test fat




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712579


Contacts
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Contact: Oonagh Markey, BSc, PhD +44 1509 222737 o.markey@lboro.ac.uk
Contact: Rebecca Dewhurst-Trigg, BSc, MSc r.dewhurst-trigg@lboro.ac.uk

Locations
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United Kingdom
Loughborough University Recruiting
Loughborough, Leicestershire, United Kingdom, LE11 3TU
Sponsors and Collaborators
Loughborough University
Investigators
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Principal Investigator: Oonagh Markey, BSc, PhD Loughborough University

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Responsible Party: Dr Oonagh Markey, Vice-Chancellor's Research Fellow, Loughborough University
ClinicalTrials.gov Identifier: NCT03712579     History of Changes
Other Study ID Numbers: R18-P124
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Inflammation
Overweight
Cardiovascular Diseases
Pathologic Processes
Body Weight
Signs and Symptoms