The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 27, 2020
May 1, 2018
3 years
January 9, 2017
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in hepatic fatty acid partitioning
Within 7 days after completion of each dietary intervention
Change in plasma metabolite concentrations
Before, and within 7 days after completion of each dietary intervention.
Change in whole-body fatty acid oxidation
Within 7 days after completion of each dietary intervention
Study Arms (2)
High-fat, low-carbohydrate diet
ACTIVE COMPARATORDietary 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.
Low-fat, high-carbohydrate diet
ACTIVE COMPARATORDietary 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, OX3 7LE, United Kingdom
Related Publications (1)
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.
PMID: 32165444DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leanne Hodson, PhD
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- PI,and research assistants undertaking measurements will be blinded to the dietary intervention the participant is undertaking.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2017
First Posted
May 9, 2017
Study Start
December 1, 2016
Primary Completion
December 1, 2019
Study Completion
March 1, 2020
Last Updated
March 27, 2020
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share
Following completion of the study, all individual data obtained from participants may potentially be shared with other researchers, both here in the United Kingdom and abroad, in appropriate circumstances. If data is to be shared with other researchers, it will be done so under fully anonymised conditions.