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Completed

NCT Number: NCT07742423

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deuterium Oxide

Other

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.

Other names: Heavy water, ²H₂O, Deuterated water

Primary outcomes

  1. 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 (%).

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: DNL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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