Clinical trial NCT03145350: The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
Official title: The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat; Liver
NAFLD
Keywords: NAFLD
Fat intake
Sugar intake
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised crossover with washout period.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in liver fat content
timeFrame: Before, and within 7 days after completion of each dietary intervention
Secondary outcomes:
measure: Change in hepatic fatty acid partitioning
timeFrame: Within 7 days after completion of each dietary intervention
measure: Change in plasma metabolite concentrations
timeFrame: Before, and within 7 days after completion of each dietary intervention.
measure: Change in whole-body fatty acid oxidation
timeFrame: Within 7 days after completion of each dietary intervention
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Centre for Diabetes, Endocrinology and Metabolism
Study officials:
affiliation: University of Oxford
name: Leanne Hodson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry SA, Rosqvist F, Mozes FE, Cornfield T, Hutchinson M, Piche ME, Hulsmeier AJ, Hornemann T, Dyson P, Hodson L. Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars. Diabetes Care. 2020 May;43(5):1134-1141. doi: 10.2337/dc19-2331. Epub 2020 Mar 12.