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

• ClinicalTrials.gov Identifier: NCT03569189
• Recruitment Status: Completed
• First Posted: June 26, 2018
• Last Update Posted: January 4, 2019
• Sponsor: Loughborough University
• Information provided by (Responsible Party): Dr Oonagh Markey, Loughborough University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inflammation; Obesity; Inflammatory Response; Cardiovascular Diseases	Other: High Fat Diet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Impact of Short-term Overfeeding With a Saturated Fat-rich Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
• Actual Study Start Date: July 2, 2018
• Actual Primary Completion Date: November 23, 2018
• Actual Study Completion Date: November 23, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United Kingdom

Loughborough University

Loughborough, Leicestershire, United Kingdom, LE11 3TU

Sponsors and Collaborators

Loughborough University

Investigators

• Principal Investigator: Oonagh Markey, BSc, PhD; Loughborough University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

• Responsible Party: Dr Oonagh Markey, Principal Investigator, Loughborough University
• ClinicalTrials.gov Identifier: NCT03569189
• Other Study ID Numbers: R18-P040
• First Posted: June 26, 2018
• Last Update Posted: January 4, 2019
• Last Verified: January 2019

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

Additional relevant MeSH terms:

Cardiovascular Diseases; Inflammation; Pathologic Processes