De Novo Lipogenesis (DNL)DNLNCT07742423
Implementation and Validation of an Analytical Protocol for Measuring de Novo Lipogenesis in the Liver Using Stable Isotopes
A study testing Deuterium oxide in people with De Novo Lipogenesis (DNL) and Lipid Metabolism, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- De Novo Lipogenesis (DNL), Lipid Metabolism, Stable Isotope Tracing
- What is being tested?
- Deuterium oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Aug 2025to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study will implement and validate an analytical approach for measuring fractional hepatic de novo lipogenesis (DNL) in healthy adults using deuterium oxide (²H₂O). Participants will consume ²H₂O according to the study schedule. Following oral administration, ²H₂O enters and enriches the body-water pool, providing a source of deuterium (²H) for incorporation into palmitate newly synthesized by the liver and subsequently exported in VLDL-triglycerides. Fasting blood samples will be collected at predefined time points throughout the study. These samples will be used to determine fractional hepatic DNL and characterize the washout of ²H₂O from the body.
- Conditions
- De Novo Lipogenesis (DNL), Lipid Metabolism, Stable Isotope Tracing, Healthy Volunteers (HV)
- Being tested
- Deuterium oxide
- Keywords
- De Novo Lipogenesis, stable isotopes, deuterium oxide, VLDL triglycerides, lipid metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium oxideOther
Also called Heavy water, ²H₂O, Deuterated water
Participants will orally consume 70% deuterium oxide (²H₂O), a non-radioactive stable isotope tracer, for 10 consecutive days. The total daily amount will be 100 mL on Days 1-4 and 50 mL on Days 5-10. The tracer will be used to label body water and newly synthesized palmitate for the measurement of fractional hepatic de novo lipogenesis and plasma-water ²H₂O washout.
| Study group | Role | What they receive |
|---|---|---|
| Deuterium oxide stable isotope labelling | Experimental | All participants will undergo a 10-day oral stable isotope labelling period with deuterium oxide (²H₂O). Blood samples will be collected at baseline, on Day 11, and at washout Weeks 4, 6, and 8. Deuterium (²H) enrichment in plasma water and VLDL-TG palmitate will be measured to determine fractional hepatic de novo lipogenesis and characterize the washout of ²H₂O. Receives: Other: Deuterium oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional hepatic de novo lipogenesis
VLDL will be isolated from fasting plasma by ultracentrifugation. Fractional hepatic de novo lipogenesis will be calculated from the ²H enrichment of VLDL-TG palmitate, normalized to plasma-water ²H enrichment and the effective number of exchangeable hydrogen positions in palmitate (n = 22), and will be expressed as a percentage (%).
Measured: Day 11
Secondary outcomes (1)
Plasma-water ²H enrichment
Plasma-water ²H enrichment will be measured at baseline, on Day 11, and at follow-up visits during the washout period to determine the time required for ²H enrichment to return close to baseline.
Measured: Baseline; Day 11; and at 4, 6, and 8 weeks following completion of the 10-day ²H₂O intake period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start25 Aug 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Novo Lipogenesis (DNL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742423
- Sponsor's protocol ID
- S70724
- Acronym
- DNL
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NO IPD data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Validation of an Analytical Protocol for Measuring de Novo Lipogenesis in the Liver Using Stable Isotopes
- ClinicalTrials.gov ID
- NCT07742423
- Acronym / sponsor ID
- DNL / S70724
- Conditions
- De Novo Lipogenesis (DNL), Lipid Metabolism, Stable Isotope Tracing, Healthy Volunteers (HV)
- Keywords
- De Novo Lipogenesis, stable isotopes, deuterium oxide, VLDL triglycerides, lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will implement and validate an analytical approach for measuring fractional hepatic de novo lipogenesis (DNL) in healthy adults using deuterium oxide (²H₂O). Participants will consume ²H₂O according to the study schedule. Following oral administration, ²H₂O enters and enriches the body-water pool, providing a source of deuterium (²H) for incorporation into palmitate newly synthesized by the liver and subsequently exported in VLDL-triglycerides. Fasting blood samples will be collected at predefined time points throughout the study. These samples will be used to determine fractional hepatic DNL and characterize the washout of ²H₂O from the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deuterium oxide stable isotope labelling | Experimental | Other: Deuterium oxideAll participants will undergo a 10-day oral stable isotope labelling period with deuterium oxide (²H₂O). Blood samples will be collected at baseline, on Day 11, and at washout Weeks 4, 6, and 8. Deuterium (²H) enrichment in plasma water and VLDL-TG palmitate will be measured to determine fractional hepatic de novo lipogenesis and characterize the washout of ²H₂O. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deuterium oxideAlso: Heavy water, ²H₂O, Deuterated waterParticipants will orally consume 70% deuterium oxide (²H₂O), a non-radioactive stable isotope tracer, for 10 consecutive days. The total daily amount will be 100 mL on Days 1-4 and 50 mL on Days 5-10. The tracer will be used to label body water and newly synthesized palmitate for the measurement of fractional hepatic de novo lipogenesis and plasma-water ²H₂O washout. | Other | Deuterium oxide stable isotope labelling |
Primary outcome
Fractional hepatic de novo lipogenesis
Time frame: Day 11
VLDL will be isolated from fasting plasma by ultracentrifugation. Fractional hepatic de novo lipogenesis will be calculated from the ²H enrichment of VLDL-TG palmitate, normalized to plasma-water ²H enrichment and the effective number of exchangeable hydrogen positions in palmitate (n = 22), and will be expressed as a percentage (%).
1 secondary outcome
Plasma-water ²H enrichment
Time frame: Baseline; Day 11; and at 4, 6, and 8 weeks following completion of the 10-day ²H₂O intake period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. NO IPD data will be shared with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deuterium oxide in people with De Novo Lipogenesis (DNL) and Lipid Metabolism, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional hepatic de novo lipogenesis (time frame: Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.