How alcohol and fats affect liver cell energy in healthy volunteers
Tests how alcohol and fat affect liver energy processing in healthy adults.
Plain-language title generated from the registry record
Registry title: Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
Key facts
- Where
- Helsinki, FinlandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06559878, who can take part
Where in Finland
- Helsinki Central University HospitalHelsinki, FinlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Helsinki University Central Hospital
- Trial code
- NCT06559878
- Record updated
- 19 August 2024
- Original description
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.Read full original descriptionShow less
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
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?
Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent; Subject must be likely to be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge; Age range from 18-75 years; No known hypersensitivity to egg, soy, or peanut protein, or to any of the substances of Intralipid 20%, or to any other substance to be administered during the study; No severe hyperlipidemia or hemophagocytotic syndrome as judged by history and physical examination and standard laboratory tests; No other liver disease except for SLD; No advanced liver disease as judged by history and physical examination and standard laboratory tests; No claustrophobia or metal implants to allow magnetic resonance studies; No pregnancy or lactation in women; No known or anticipated difficulties in cannulation of peripheral veins; No history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion; No drinking problem based on AUDIT questionnaire; No use of medications interacting with alcohol; No history of heparin induced thrombosytopenia (HIT) or bleeding tendency; No current use of warfarin, direct anticoagulants, or thrombocyte inhibitors.