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NCT Number: NCT03712579

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

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.

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Key information

Conditions

Inflammation Body Weight Cardiovascular Diseases Inflammatory Response Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SFA-Rich Meal

Dietary Supplement

Saturated fatty acid-rich test meal, containing 75g test fat

MUFA-Rich Meal

Dietary Supplement

Monounsaturated fatty acid-rich test meal, containing 75g test fat

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Registry information

Official study title

Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses: a Randomized Controlled Postprandial Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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