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

NCT03712579 | Completed

• 1 other identifier: R18-P124
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Obesity; Inflammatory Response; Cardiovascular Diseases; Overweight

Outcome Measures

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)

  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 Outcomes (5)

• Systemic Markers of Inflammation (for example TNFa and IL-6 concentrations, determined using an ELISA)

  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

  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)

  Blood samples will be collected at -0.5 (fasted) and 4 hours postprandially

• Serum Markers of Insulin Resistance

  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)

  Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially

Study Arms (2)

SFA-Rich Meal

EXPERIMENTAL

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

MUFA-Rich Meal

EXPERIMENTAL

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

Interventions

SFA-Rich Meal DIETARY_SUPPLEMENT

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

SFA-Rich Meal

MUFA-Rich Meal DIETARY_SUPPLEMENT

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

MUFA-Rich Meal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Inflammation; Obesity; Cardiovascular Diseases; Overweight

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Oonagh Markey, BSc, PhD

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chancellor's Research Fellow

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: October 19, 2018
• Study Start: January 21, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

GB (1)