Back to resultsThe Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
Primary Purpose
Fat; Liver, NAFLD
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-fat, low-carbohydrate
Low-fat, high-carbohydrate
Sponsored by
About this trial
This is an interventional basic science trial for Fat; Liver focused on measuring NAFLD, Fat intake, Sugar intake
Eligibility 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
Sites / Locations
- Oxford Centre for Diabetes, Endocrinology and Metabolism
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High-fat, low-carbohydrate diet
Low-fat, high-carbohydrate diet
Arm 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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03145350
Brief Title
The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
Official Title
The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat; Liver, NAFLD
Keywords
NAFLD, Fat intake, Sugar intake
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised crossover with washout period.
Masking
Investigator
Masking Description
PI,and research assistants undertaking measurements will be blinded to the dietary intervention the participant is undertaking.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-fat, low-carbohydrate diet
Arm Type
Active Comparator
Arm 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.
Arm Title
Low-fat, high-carbohydrate diet
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
High-fat, low-carbohydrate
Intervention Description
Dietary intervention: 4 week
Intervention Type
Other
Intervention Name(s)
Low-fat, high-carbohydrate
Intervention Description
Dietary intervention: 4 week
Primary Outcome Measure Information:
Title
Change in liver fat content
Description
Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).
Time Frame
Before, and within 7 days after completion of each dietary intervention
Secondary Outcome Measure Information:
Title
Change in hepatic fatty acid partitioning
Description
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.
Time Frame
Within 7 days after completion of each dietary intervention
Title
Change in plasma metabolite concentrations
Description
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.
Time Frame
Before, and within 7 days after completion of each dietary intervention.
Title
Change in whole-body fatty acid oxidation
Description
Investigators will utilise stable isotope tracer methodology to measure whole-body dietary fatty acid oxidation after each of the 4 week intervention diets.
Time Frame
Within 7 days after completion of each dietary intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Hodson, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Centre for Diabetes, Endocrinology and Metabolism
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32165444
Citation
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.
Results Reference
derived
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The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
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