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

May 15, 2022 updated by: Dr Oonagh Markey, Loughborough University

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

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Leicestershire
      • Loughborough, Leicestershire, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 15, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • R18-P124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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