At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Diet (behavioural)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Diet — behavioural: High fat (\~60% of total energy intake) diet enriched with either SFA or UFA
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 26
- Started
- 2023-02-15
- Last checked
- 2023-03
Plain English Summary
What is this study?
- • Testing a new treatment for liver fat
- • NA - 26 participants
- • Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with liver fat
Where?
- • Oxford - Oxford Centre for Diabetes, Endocrinology and Metabolism
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk. To explore this, we are undertaking a human in vivo parallel-design study, comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on postprandial metabolism, liver fat, cardiac fat and cardiac function.
More detail
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 fat consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver fat metabolism when someone is not gaining or losing body weight?" To address this research question investigators want to undertake detail physiological studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to assess how their metabolic response to a experimental test meal, before and then 28 days after consumption of a eucaloric, high fat intervention diet that will be either enriched in saturated or unsaturated fat.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓The participant is willing and able to give agreement to take part for participation in the study.
- ✓Male or Female, aged ≥18 or ≤65 years.
- ✓Body Mass Index ≥19 ≤35 kg/m2
- ✓No medical condition or relevant drug therapy that is known to affect liver or adipose tissue metabolism.
- ✓Weight stable for the previous 3 months
Who cannot take part
- ✗The participant is unwilling or unable to give agreement to take part for participation in the study. - Aged ≤18 or ≥65 years
- ✗Body Mass Index ≤19 or ≥35kg/m2
- ✗Blood haemoglobin \<135mg/dL for men and \<120mg/dL for women
- ✗Donated (or lost) ≥250 ml of blood in the previous two months.
- ✗On a weight loss diet or have decreased their body weight by \>5% in the previous 3 months.
See the full criteria
Where Is This Study? (1 UK site)
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Leanne Hodson
Sponsor contactCONTACT
