ClinicalTrials.Veeva

Menu

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

University of Oxford logo

University of Oxford

Status

Completed

Conditions

Fat; Liver
NAFLD

Treatments

Other: Low-fat, high-carbohydrate
Other: High-fat, low-carbohydrate

Study type

Interventional

Funder types

Other

Identifiers

NCT03145350
Oxlip-2017-HFD/HSD

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

16 participants in 2 patient groups

High-fat, low-carbohydrate diet
Active Comparator group
Description:
Dietary intervention: Participants will consume a diet that is rich in saturated fat (20% total energy) and low in free sugars for 4 weeks. This diet will include commonly eaten foods such as butter, cheese, and fatty meat products. Total fat intake in this intervention will be 40-45% total energy.
Treatment:
Other: High-fat, low-carbohydrate
Low-fat, high-carbohydrate diet
Active Comparator group
Description:
Dietary intervention: Participants will consume a diet that is low in saturated fat (~5% total energy) and rich in free sugars (20% total energy).The diet will include commonly eaten food and drink such as sugar sweetened beverages, confectionery (e.g. fruit gums) and table sugar.
Treatment:
Other: Low-fat, high-carbohydrate

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems