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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569189
• Other study ID #: R18-P040
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: January 2019
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Inflammation
• Inflammatory Response
• Obesity

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.

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)