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

Primary Purpose

Inflammation, Obesity, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SFA-Rich Meal
MUFA-Rich Meal
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SFA-Rich Meal

MUFA-Rich Meal

Arm Description

Participants will consume a SFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected

Participants will consume a MUFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Gene expression of key markers of metabolic inflammation in white adipose tissue
This will be assessed following the collection of white adipose tissue samples
Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)
Assessed following the collection of blood samples
Serum Markers of Insulin Resistance
Assessed following the collection of blood samples
Serum Lipid Profile (primarily triacylglycerol and non-esterified fatty acid concentrations, measured using a spectrophotometric assay)
Assessed following the collection of blood samples

Full Information

First Posted
June 6, 2018
Last Updated
May 15, 2022
Sponsor
Loughborough University
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1. Study Identification

Unique Protocol Identification Number
NCT03712579
Brief Title
Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses
Official Title
Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses: a Randomized Controlled Postprandial Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Obesity, Inflammatory Response, Cardiovascular Diseases, Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFA-Rich Meal
Arm Type
Experimental
Arm Description
Participants will consume a SFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected
Arm Title
MUFA-Rich Meal
Arm Type
Experimental
Arm Description
Participants will consume a MUFA-rich test meal (75g test fat) and sequential blood and white adipose tissue samples will be collected
Intervention Type
Dietary Supplement
Intervention Name(s)
SFA-Rich Meal
Intervention Description
Saturated fatty acid-rich test meal, containing 75g test fat
Intervention Type
Dietary Supplement
Intervention Name(s)
MUFA-Rich Meal
Intervention Description
Monounsaturated fatty acid-rich test meal, containing 75g test fat
Primary Outcome Measure Information:
Title
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)
Description
This will be assessed following the collection of white adipose tissue samples across the postprandial period
Time Frame
White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
Secondary Outcome Measure Information:
Title
Systemic Markers of Inflammation (for example TNFa and IL-6 concentrations, determined using an ELISA)
Description
This will be assessed following the collection of blood samples
Time Frame
Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Title
Gene expression of key markers of metabolic inflammation in white adipose tissue
Description
This will be assessed following the collection of white adipose tissue samples
Time Frame
White adipose tissue samples will be collected at -0.5 (fasted), 1, 4 and 6 hours postprandially
Title
Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)
Description
Assessed following the collection of blood samples
Time Frame
Blood samples will be collected at -0.5 (fasted) and 4 hours postprandially
Title
Serum Markers of Insulin Resistance
Description
Assessed following the collection of blood samples
Time Frame
Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Title
Serum Lipid Profile (primarily triacylglycerol and non-esterified fatty acid concentrations, measured using a spectrophotometric assay)
Description
Assessed following the collection of blood samples
Time Frame
Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oonagh Markey, BSc, PhD
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

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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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