CompletedNot Applicable

Implementation and Validation of an Analytical Protocol for Measuring de Novo Lipogenesis in the Liver Using Stable Isotopes

Belgium10 participantsStarted 2025-08-25

Plain-language summary

During this study, an analytical protocol for measuring hepatic de novo lipogenesis (DNL) using deuterium oxide (²H₂O) will be implemented and validated in healthy participants.

Who can participate

Age range

18 Years – 60 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: * Healthy male or female individuals. * Age between 18-60 years old with a body mass index (BMI) between 18.5 and 25 kg/m². * Willingness to consume ²H₂O as part of the study protocol. Exclusion Criteria: Participants will be excluded from the study based on self-reported health status if they meet any of the following conditions: * Chronic diseases (e.g., diabetes, MASLD, hypertension, cardiovascular diseases) and/or chronic consumption of medication (e.g., antihypertensive drugs, diabetes medications, lipid-lowering agents, immunomodulatory drugs, or other prescribed medications for long-term management of health conditions). * History of blood donation within the past 3 months. * Vaccination within the past 4 weeks. * Pregnancy or breastfeeding. * Participation in another clinical study.

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

Fractional hepatic de novo lipogenesis

Timeframe: Day 11

Trial details

NCT IDNCT07742423

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-11

View on ClinicalTrials.gov More De Novo Lipogenesis (DNL) trials

Who can participate

Age range

18 Years – 60 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.