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

NCT03569189 | Completed

• 1 other identifier: R18-P040
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation; Obesity; Inflammatory Response; Cardiovascular Diseases

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 fasted white adipose tissue samples

  Change between pre- and post-high fat diet (assessed on days 4 and 11)

Secondary Outcomes (8)

• Systemic Markers of Inflammation (for example CRP, TNFa and IL-6 concentrations, determined by spectrophotometric assay/ ELISA)

  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

  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)

  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)

  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)

  Change between pre- and post-high fat diet (assessed on days 4 and 11)

Study Arms (1)

High Fat Diet

EXPERIMENTAL

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

Interventions

High Fat Diet OTHER

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.

High Fat Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32232380 DERIVED

MeSH Terms

Conditions

Inflammation; Obesity; Cardiovascular Diseases

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Oonagh Markey, BSc, PhD

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 26, 2018
• Study Start: July 2, 2018
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

GB (1)