HypertriglyceridaemiaNCT02478541
Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Sugars on Liver Fat Metabolism
A study testing Sugar study in people with Hypertriglyceridaemia, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridaemia
- What is being tested?
- Sugar study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, OX3 7LE
About this study
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
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.
Read the 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.
- Conditions
- Hypertriglyceridaemia
- Being tested
- Sugar study
- Keywords
- triglycerides, glucose, fructose, fatty acids
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Study_low fructose | Active comparator | 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 Receives: Other: Sugar study |
| Sugar Study_high fructose | Active comparator | 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 Receives: Other: Sugar study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 hours
Secondary outcomes (1)
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.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridaemiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leanne Hodson, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478541
- Sponsor's protocol ID
- Oxlip-2013_expt2
- Status last verified
- Nov 2016
- First submitted
- 15 Jun 2015
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02478541
- Acronym / sponsor ID
- Oxlip-2013_expt2
- Conditions
- Hypertriglyceridaemia
- Keywords
- triglycerides, glucose, fructose, fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Study_low fructose | Active comparator | Other: Sugar studyConsumption of a single test meal that contains fat and a sugary drink made with a low amount of fructose and high amount of glucose |
| Sugar Study_high fructose | Active comparator | Other: Sugar studyConsumption of a single test meal that contains fat and a sugary drink made with a high amount of fructose and low amount of glucose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar studySubjects 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. | Other | Sugar Study_high fructose, Sugar Study_low fructose |
Primary outcome
Plasma Triglycerides
Time frame: 7 hours
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.
1 secondary outcome
Plasma glucose
Time frame: 7 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne Hodson, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar study in people with Hypertriglyceridaemia, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Triglycerides (time frame: 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.