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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712579
• Other study ID #: R18-P124
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: May 2022
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Inflammation
• Inflammatory Response
• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Secondary	Gene expression of key markers of metabolic inflammation in white adipose tissue	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
Secondary	Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells (measured using flow cytometry analysis)	Assessed following the collection of blood samples	Blood samples will be collected at -0.5 (fasted) and 4 hours postprandially
Secondary	Serum Markers of Insulin Resistance	Assessed following the collection of blood samples	Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially
Secondary	Serum Lipid Profile (primarily triacylglycerol and non-esterified fatty acid concentrations, measured using a spectrophotometric assay)	Assessed following the collection of blood samples	Blood samples will be collected at -0.5 (fasted) until 6 hours postprandially