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ENROLLING BY INVITATION
NCT06559878
NA

Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to investigate in healthy volunteers the mechanisms by which ethanol and lipids, the two key risk factors of steatotic liver disease (SLD), affect liver mitochondrial metabolism. The main question it aims to answer is: • Does acute administration of ethanol and lipids increase hepatic mitochondrial reductive stress as determined by orally ingested stable isotope tracer 13C-alpha-ketoisocaproate and by plasma beta-hydroxybutyrate to acetoacetate ratio (b-OHB/AcAc) in humans?

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-09-01

Completion Date

2027-01-31

Last Updated

2024-08-19

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

13C-α-Ketoisocaproic Acid Breath Test

13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).

DIETARY_SUPPLEMENT

Ethanol

6% ethanol soluted in normal saline is given intravenously during one metabolic visit.

DIETARY_SUPPLEMENT

Lipid Emulsion

Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.

OTHER

Normal Saline

Normal saline is given intravenously during one metabolic visit.

Locations (1)

Helsinki Central University Hospital

Helsinki, Uusimaa, Finland