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Completed

NCT Number: NCT03569189

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

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.

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Key information

Conditions

Inflammation Body Weight Cardiovascular Diseases Inflammatory Response Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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)

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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