Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses

Impact of Short-term Overfeeding With a Saturated Fat-rich Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses

This study will investigate the effect of a 7-day westernised high-fat (65% of kilocalories), high-calorie (150% of requirements) diet on markers of inflammation in the blood and white adipose tissue. Participants will firstly complete a 3-day weight maintenance phase (Days 1-3) before completing a 7-day high fat diet intervention (Days 4-10). On days 4 and 11 participants will complete a laboratory visit where anthropometric measurements, blood and adipose samples will be collected.

The investigators hypothesise that consuming a high-fat, high-calorie diet for 7 days will alter the inflammatory responses in white adipose tissue and will induce metabolic endotoxaemia / systemic inflammation.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Inflammation; Obesity; Inflammatory Response
• Intervention / Treatment: Other: High Fat Diet

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 18-40 years
• BMI = 21.0-29.9 kg/m2
• Male or female
• Physically active (> 3 x 30 min moderate exercise per week)
• Healthy
• No cardiometabolic (e.g. heart disease, high blood pressure, type 2 diabetes) or inflammatory illness

Exclusion criteria:

• Inactive (< 3 x 30 min moderate exercise per week)
• Smoker
• Women who are pregnant or lactating
• Medication/supplements known to interfere with study outcomes or prescribed antibiotics within the last 3 months
• Unstable weight history (≥3kg loss or gain in the previous 3 months)
• An allergy to lidocaine
• Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose) which could impede compliance to the diet
• Vegetarian/ vegan (as the high-fat diet is based on animal fats)
• Consumption of probiotics yogurts during or within the four weeks prior to the start of the study (e.g. Actimel, Activia, Yakult, Yeo Valley)
• Alcohol consumption >28 units per week for a man (i.e. not more than 14 pints of beer or 28 small glasses of wine) or >21 units per week for a woman (i.e. more than 10 and a half pints of beer or 21 small glasses of wine)
• 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
• Restrained eaters (determined by Three Factor Eating Questionnaire)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Fat Diet; Participants will consume a high-fat, high-calorie diet for 7 days (i.e. westernised diet) following a 3-day weight maintenance diet. Measurements will be made pre- and post-high fat diet intervention.	Other: High Fat Diet; Participants will consume a high fat diet for 7 days with 65% of energy from fat. The diet will also provide an energy excess at 150% of energy requirements. Participants will be provided with all of their meals and snacks throughout the study.

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)	This will be assessed following the collection of fasted white adipose tissue samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Markers of Inflammation (for example CRP, TNFa and IL-6 concentrations, determined by spectrophotometric assay/ ELISA)	Assessed following the collection of fasted blood samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Gene expression of key markers of metabolic inflammation in white adipose tissue	This will be assessed following the collection of fasted white adipose tissue samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)	Assessed following the collection of fasted blood samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG and NEFA concentrations, measured using a spectrophotometric assay)	Assessed following the collection of fasted blood samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Systemic Markers of Metabolic Endotoxemia (for example LBP and sCD14 concentrations, determined using an ELISA)	Assessed following the collection of fasted blood samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Immune Cell Populations in the Blood	Assessed following the collection of fasted blood samples	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)	Measured using standard equipment	Change between pre- and post-high fat diet (assessed on days 4 and 11)
Physical Activity	Assessed using Actigraph accelerometers	Habitual physical activity will be assessed for 3 days prior to commencing the high-fat diet intervention (days 1-3) and during the final 3 days of the intervention (days 8-10)

Collaborators and Investigators

• Sponsor: Loughborough University

Publications and helpful links

General Publications

• Dewhurst-Trigg R, Wadley AJ, Woods RM, Sherar LB, Bishop NC, Hulston CJ, Markey O. Short-term High-fat Overfeeding Does Not Induce NF-kappaB Inflammatory Signaling in Subcutaneous White Adipose Tissue. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa158. doi: 10.1210/clinem/dgaa158.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2018
• Primary Completion (ACTUAL): November 23, 2018
• Study Completion (ACTUAL): November 23, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Inflammation
• Other Study ID Numbers: R18-P040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No