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

Primary Purpose

Inflammation, Obesity, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Fat Diet
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Fat Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
Systemic Markers of Metabolic Endotoxemia (for example LBP and sCD14 concentrations, determined using an ELISA)
Assessed following the collection of fasted blood samples
Immune Cell Populations in the Blood
Assessed following the collection of fasted blood samples
Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)
Measured using standard equipment
Physical Activity
Assessed using Actigraph accelerometers

Full Information

First Posted
May 22, 2018
Last Updated
January 3, 2019
Sponsor
Loughborough University
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1. Study Identification

Unique Protocol Identification Number
NCT03569189
Brief Title
Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
Official Title
Impact of Short-term Overfeeding With a Saturated Fat-rich Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
November 23, 2018 (Actual)
Study Completion Date
November 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Obesity, Inflammatory Response, Cardiovascular Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oonagh Markey, BSc, PhD
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32232380
Citation
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.
Results Reference
derived

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

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