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Completed

NCT Number: NCT03145350

The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism

Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world. It is currently unclear why fat starts to accumulate in the liver, although both the amount and type of food consumed have been implicated. The majority of studies that have investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess calories, which are known to increase liver fat. The effect of specific dietary components, when consumed as part of a diet not containing excess calories, on liver fat accumulation remains unclear.

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Key information

Conditions

Fat; Liver Digestive System Diseases Fatty Liver Liver Diseases NAFLD Non-alcoholic Fatty Liver Disease

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX3 7LE, United Kingdom

About this study

This research aims to investigate the role excessive consumption of specific macronutrients may play in the development of NAFLD. This will be achieved by subjecting participants to two specific dietary interventions (high-fat, low-carbohydrate and low-fat, high-carbohydrate) in a randomized, crossover research design. Liver fat content, and whole-body and hepatic fasting and postprandial lipid metabolism will be assessed before and after the specific dietary interventions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • BMI >25 <35kg/m2
  • No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism

Exclusion criteria

  • Age <30 or >65 years
  • Body mass index <25 or >35kg/m2
  • A blood haemoglobin <120mg/dL
  • Any metabolic condition or relevant drug therapy
  • People who do not tolerate fructose
  • Smoking
  • History of alcoholism or a greater than recommended alcohol intake
  • Pregnant or nursing mothers
  • Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
  • History of severe claustrophobia
  • Presence of metallic implants, pacemaker
  • Haemorrhagic disorders
  • Anticoagulant treatment

Treatment and study plan

High-fat, low-carbohydrate

Other

Dietary intervention: 4 week

Low-fat, high-carbohydrate

Other

Dietary intervention: 4 week

Primary outcomes

  1. Change in liver fat content

    Time frame: Before, and within 7 days after completion of each dietary intervention

    Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).

Secondary outcomes

  1. Change in hepatic fatty acid partitioning

    Time frame: Within 7 days after completion of each dietary intervention

    Investigators will utilise stable isotope tracer methodology to measure the contribution of newly synthesised fatty acids and dietary fatty acids to triglyceride production and oxidation pathways in the liver after each of the 4 week intervention diets.

  2. Change in plasma metabolite concentrations

    Time frame: Before, and within 7 days after completion of each dietary intervention.

    Circulating concentrations of glucose, insulin, non-esterified fatty acids, and triglycerides will be measured biochemically using a clinical analyser after each of the 4 week intervention diets.

  3. Change in whole-body fatty acid oxidation

    Time frame: Within 7 days after completion of each dietary intervention

    Investigators will utilise stable isotope tracer methodology to measure whole-body dietary fatty acid oxidation after each of the 4 week intervention diets.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 9, 2017
Registry last updated
Mar 27, 2020

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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