Clinical trial NCT03569189: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Obesity
Inflammatory Response
Cardiovascular Diseases
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: 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)
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
Secondary outcomes:
measure: Systemic Markers of Inflammation (for example CRP, TNFa and IL-6 concentrations, determined by spectrophotometric assay/ ELISA)
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Gene expression of key markers of metabolic inflammation in white adipose tissue
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Fasting Serum Markers of Insulin Resistance (for example insulin and glucose concentrations, determined using an ELISA/ spectrophotometric assay)
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG and NEFA concentrations, measured using a spectrophotometric assay)
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Systemic Markers of Metabolic Endotoxemia (for example LBP and sCD14 concentrations, determined using an ELISA)
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Immune Cell Populations in the Blood
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)
timeFrame: Change between pre- and post-high fat diet (assessed on days 4 and 11)
measure: Physical Activity
timeFrame: 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)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Oonagh Markey, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.