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

NCT ID: NCT03145350

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Fat; Liver NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised crossover with washout period.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
PI,and research assistants undertaking measurements will be blinded to the dietary intervention the participant is undertaking.

Study Groups

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High-fat, low-carbohydrate diet

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.

Group Type ACTIVE_COMPARATOR

High-fat, low-carbohydrate

Intervention Type OTHER

Dietary intervention: 4 week

Low-fat, high-carbohydrate diet

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.

Group Type ACTIVE_COMPARATOR

Low-fat, high-carbohydrate

Intervention Type OTHER

Dietary intervention: 4 week

Interventions

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High-fat, low-carbohydrate

Dietary intervention: 4 week

Intervention Type OTHER

Low-fat, high-carbohydrate

Dietary intervention: 4 week

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leanne Hodson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32165444 (View on PubMed)

Other Identifiers

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Oxlip-2017-HFD/HSD

Identifier Type: -

Identifier Source: org_study_id

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