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

NCT07742423 | Completed DMC

• 1 other identifier: S70724
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

De Novo Lipogenesis (DNL); Lipid Metabolism; Healthy Volunteers (HV); Stable Isotope Tracing

Keywords

De Novo Lipogenesis; stable isotopes; deuterium oxide; VLDL triglycerides; lipid metabolism

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  Day 11

Secondary Outcomes (1)

• Plasma-water ²H enrichment

  Baseline; Day 11; and at 4, 6, and 8 weeks following completion of the 10-day ²H₂O intake period.

Study Arms (1)

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.

Other: Deuterium oxide

Interventions

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.

Also known as: Heavy water, ²H₂O, Deuterated water

Deuterium oxide stable isotope labelling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

Deuterium Oxide

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Deuterium; Hydrogen; Elements; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 3, 2026
• Study Start: August 25, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)