NCT05962190Recruiting
Short-term Fat Overfeeding on the Effects of Liver Metabolism
The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.
Source: ClinicalTrials.gov · Last updated 27 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 20 Mar 2023
- Start date
- 15 Feb 2023
- Primary completion date
- Feb 2028
- Lead sponsor
- University of Oxford
- NCT number
- NCT05962190
What you commit to
- Study type: Interventional
- Planned participants: 26
- From 15 Feb 2023 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Presence of metallic implants, pacemakers, or are unwilling to remove any piercings
Other illness
- Any metabolic condition or relevant drug therapy
- 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
- 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
- History of an eating disorder or any other psychological condition that may affect the participant's ability to adhere to study intervention/experimental diets.
Lab values
- Blood haemoglobin \<135mg/dL for men and \<120mg/dL for women
- History of albumin allergy
Age
- The participant is unwilling or unable to give informed consent for participation in the study. - Aged ≤18 or ≥65 years
Other
- Body Mass Index ≤19 or ≥35kg/m2
- Current smoker
- Anticoagulant treatment
- Pregnant or nursing mothers
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oxford Centre for Diabetes, Endocrinology and Metabolism Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.