Implementation and Validation of an Analytical Protocol for Measuring de Novo Lipogenesis in the Liver Using Stable Isotopes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Fractional hepatic de novo lipogenesis
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
- Plasma-water ²H enrichment(Baseline; Day 11; and at 4, 6, and 8 weeks following completion of the 10-day ²H₂O intake period.)
Investigators
Kristin Verbeke
Prof.
KU Leuven