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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145350
• Other study ID #: Oxlip-2017-HFD/HSD
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 2020

Study information

• Verified date: May 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fat; Liver
• Fatty Liver
• NAFLD

Intervention

Other:
• High-fat, low-carbohydrate
Dietary intervention: 4 week
• Low-fat, high-carbohydrate
Dietary intervention: 4 week

Locations

Country	Name	City	State
United Kingdom	Oxford Centre for Diabetes, Endocrinology and Metabolism	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver fat content	Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).	Before, and within 7 days after completion of each dietary intervention
Secondary	Change in hepatic fatty acid partitioning	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.	Within 7 days after completion of each dietary intervention
Secondary	Change in plasma metabolite concentrations	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.	Before, and within 7 days after completion of each dietary intervention.
Secondary	Change in whole-body fatty acid oxidation	Investigators will utilise stable isotope tracer methodology to measure whole-body dietary fatty acid oxidation after each of the 4 week intervention diets.	Within 7 days after completion of each dietary intervention