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

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ClinicalTrials.gov Identifier: NCT03145350
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Fat; Liver NAFLD Other: High-fat, low-carbohydrate Other: Low-fat, high-carbohydrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised crossover with washout period.
Masking: Single (Investigator)
Masking Description: PI,and research assistants undertaking measurements will be blinded to the dietary intervention the participant is undertaking.
Primary Purpose: Basic Science
Official Title: The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: High-fat, low-carbohydrate
Dietary intervention: 4 week

Active Comparator: 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.
Other: Low-fat, high-carbohydrate
Dietary intervention: 4 week




Primary Outcome Measures :
  1. Change in liver fat content [ Time Frame: Before, and within 7 days after completion of each dietary intervention ]
    Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).


Secondary Outcome Measures :
  1. Change in hepatic fatty acid partitioning [ Time Frame: Within 7 days after completion of each dietary intervention ]
    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.

  2. Change in plasma metabolite concentrations [ Time Frame: Before, and within 7 days after completion of each dietary intervention. ]
    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.

  3. Change in whole-body fatty acid oxidation [ Time Frame: Within 7 days after completion of each dietary intervention ]
    Investigators will utilise stable isotope tracer methodology to measure whole-body dietary fatty acid oxidation after each of the 4 week intervention diets.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145350


Locations
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United Kingdom
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Leanne Hodson, PhD University of Oxford
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03145350    
Other Study ID Numbers: Oxlip-2017-HFD/HSD
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by University of Oxford:
NAFLD
Fat intake
Sugar intake
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases