Short-term Fat Overfeeding on the Effects of Liver Metabolism
Recruiting · NCT05962190 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Oxford
View the official record on ClinicalTrials.gov →Interventions studied
Diet
What this trial is about
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 take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Oxford Centre for Diabetes, Endocrinology and Metabolism - Oxford, United Kingdom