KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
NCT Number: NCT07742423
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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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be excluded from the study based on self-reported health status if they meet any of the following conditions:
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
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 (%).
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.
KU Leuven
Other
Acronym: DNL
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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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