Short-term Fat Overfeeding on the Effects of Liver Metabolism (NCT05962190) | Clinical Trial Compass
RecruitingNot Applicable
Short-term Fat Overfeeding on the Effects of Liver Metabolism
United Kingdom26 participantsStarted 2023-02-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Liver fat
Timeframe: Pre- and after approx 28 days of consuming interventional diet