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Short-term Fat Overfeeding on the Effects of Liver Metabolism

Sponsor: University of Oxford

NCT ID: NCT05962190

View on ClinicalTrials.gov ↗

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.

Liver FatCardiac FunctionLipid DisorderAdiposity

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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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
Inclusion Criteria: * The participant is willing and able to give informed consent 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 Exclusion Criteria: * The participant is unwilling or unable to give informed consent 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. * Have increased their body weight by \>5% in the previous 3 months. * Any metabolic condition or relevant drug therapy * Current smoker * History of alcoholism or a greater than recommended alcohol intake (\>30 g of alcohol daily for men and \>20 g of alcohol daily for women) * Haemorrhagic disorders * Anticoagulant treatment * History of albumin allergy * 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, pacemakers, or are unwilling to remove any piercings * History of an eating disorder or any other psychological condition that may affect the participant's ability to adhere to study intervention/experimental diets.

Where Is This Study? (1 UK site)

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Leanne Hodson, PhDPrincipal Investigator

How to Get in Touch

Leanne Hodson

Sponsor contact

CONTACT

01865 857224 leanne.hodson@ocdem.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2023-03