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Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Sugars on Liver Fat Metabolism

Primary Purpose

Hypertriglyceridaemia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Sugar study

About this trial

This is an interventional basic science trial for Hypertriglyceridaemia focused on measuring triglycerides, glucose, fructose, fatty acids

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.
BMI >19 <35kg/m2
No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism

Exclusion Criteria:

Age <18 or >65 years
Body mass index <19 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

Arm Label

Sugar Study_low fructose

Sugar Study_high fructose

Arm Description

Consumption of a single test meal that contains fat and a sugary drink made with a low amount of fructose and high amount of glucose

Consumption of a single test meal that contains fat and a sugary drink made with a high amount of fructose and low amount of glucose

Outcomes

Primary Outcome Measures

Plasma Triglycerides

Postprandial plasma triglyceride concentrations will be measured biochemically, on a clinical analyser by taking regular blood samples from participants for a period of up to 7 hours after participants have consumed the test meal.

Secondary Outcome Measures

Plasma glucose

Postprandial plasma glucose concentrations will be measured biochemically, by taking blood samples from participants regularly after the consumption of a mixed test meal.

Full Information

NCT ID

NCT02478541

First Posted

June 15, 2015

Last Updated

January 19, 2017

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT02478541

Brief Title

Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Sugars on Liver Fat Metabolism

Official Title

Investigating Intra-hepatic Fatty Acid Partitioning and Its Regulation in Man. Studies to Understand the Role of Dietary Nutrients in Liver Fat Metabolism in Relation to Obesity in Man

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

High levels of fatty substances in the blood increase the risk of developing coronary heart disease and having a heart attack. The investigators know a lot about one of these fatty substances, cholesterol. However, there is another fatty substance in the blood called triglyceride. The investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). The investigators are developing new techniques to measure these processes in healthy people. Ultimately a deeper understanding of the regulation of this process might lead to the development of new treatments for fat accumulation in the liver and high blood fat levels and related disorders. The present study is an investigation of how these processes relate to various bodily characteristics such as thinness and fatness and the distribution of fat in the body.

Detailed Description

The investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism. Purpose and design: The investigators are asking the research question: "How does the amount and type of sugars consumed, such as those found in soft drinks, influence postprandial fatty acid and liver fat metabolism?" It is known that consuming fructose by itself or with glucose can increase plasma triglyceride concentrations and liver fat amounts but it remains unclear how this happens. To address this research question investigators want to undertake detail physiological studies, in a randomised cross-over study where individuals will be studied twice after the consumption of a single test meal that will contain different amounts of glucose and fructose with the same amount of dietary fat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridaemia

Keywords

triglycerides, glucose, fructose, fatty acids

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sugar Study_low fructose

Arm Type

Active Comparator

Arm Description

Consumption of a single test meal that contains fat and a sugary drink made with a low amount of fructose and high amount of glucose

Arm Title

Sugar Study_high fructose

Arm Type

Active Comparator

Arm Description

Consumption of a single test meal that contains fat and a sugary drink made with a high amount of fructose and low amount of glucose

Intervention Type

Other

Intervention Name(s)

Sugar study

Intervention Description

Subjects are given a single test meal on two study days that has a sugary drink that varies in the amount of fructose and glucose it contains. They consume the same amount of fat on both study days.

Primary Outcome Measure Information:

Title

Plasma Triglycerides

Description

Time Frame

7 hours

Secondary Outcome Measure Information:

Title

Plasma glucose

Description

Postprandial plasma glucose concentrations will be measured biochemically, by taking blood samples from participants regularly after the consumption of a mixed test meal.

Time Frame

7 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. BMI >19 <35kg/m2 No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism Exclusion Criteria: Age <18 or >65 years Body mass index <19 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

Learn more about this trial

Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Sugars on Liver Fat Metabolism

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