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Non-alcoholic Fatty Liver Disease NAFLDALPHANCT06559878

Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans

A study testing 13C-α-Ketoisocaproic Acid Breath Test, Ethanol and Lipid Emulsion in people with Non-alcoholic Fatty Liver Disease NAFLD, run by Helsinki University Central Hospital at 1 site in Finland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Non-alcoholic Fatty Liver Disease NAFLD
What is being tested?
13C-α-Ketoisocaproic Acid Breath Test, Ethanol and Lipid Emulsion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteFinland
Study dates
1 Sep 2024to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult
  1. Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  2. 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.
  3. Age range from 18-75 years.
  4. 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.
  5. No severe hyperlipidemia or hemophagocytotic syndrome as judged by history and physical examination and standard laboratory tests.
  6. No other liver disease except for SLD.
  7. No advanced liver disease as judged by history and physical examination and standard laboratory tests.
  8. No claustrophobia or metal implants to allow magnetic resonance studies.
  9. No pregnancy or lactation in women.
  10. No known or anticipated difficulties in cannulation of peripheral veins.
  11. 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.
  12. No drinking problem based on AUDIT questionnaire.
  13. No use of medications interacting with alcohol.
  14. No history of heparin induced thrombosytopenia (HIT) or bleeding tendency.
  15. No current use of warfarin, direct anticoagulants, or thrombocyte inhibitors.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Finland1 site

  • Helsinki Central University Hospital

    Helsinki, Uusimaa, 00290

Other trials in Finland

About this study

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?
Read the detailed description

In this study we investigate the effects of ethanol and lipids on hepatic mitochondrial metabolism in healthy volunteers.

At first visit, an informed consent will be obtained, followed by assessment of inclusion/exclusion criteria. Participants fulfilling the criteria will be enrolled in the study. Body composition will be determined with bioelectrical impedance.

At second visit hepatic lipid content will be measured with magnetic resonance spectroscopy.

Participants will be given in random order on three separate visits (3-5):

  • Intravenous infusion of ethanol and normal saline (breath alcohol content target and upper limit corresponding to 0.6 per mil in blood)
  • Intravenous infusions of lipid emulsion, heparin and normal saline
  • Intravenous infusion of normal saline

On study visits participant will drink a tracer dose of 13C-alpha-ketoisocaproate and L-Leucine. Breath samples are collected at different time points for determination of 13C enrichment of CO2. Furthermore "arterialized" blood samples are taken during study visits to obtain beta-hydroxybutyrate to acetoacetate ratios (b-OHB/AcAc) at different timepoints.

Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.

Being tested
13C-α-Ketoisocaproic Acid Breath Test, Ethanol, Lipid Emulsion, Normal Saline
Keywords
Hepatic mitochondrial dysfunction, MAFLD, Non-alcoholic Fatty Liver Disease NAFLD, 13C-α-Ketoisocaproic Acid Breath Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13C-α-Ketoisocaproic Acid Breath TestDiagnostic test

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

  • EthanolDietary supplement

    Also called Alcohol

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

  • Lipid EmulsionDietary supplement

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

  • Normal SalineOther

    Normal saline is given intravenously during one metabolic visit.

Study groups in NCT06559878
Study groupRoleWhat they receive
The order of metabolic visits: 1.Normal saline, 2.Lipid emulsion, 3.EthanolExperimentalNot described
Receives: Diagnostic Test: 13C-α-Ketoisocaproic Acid Breath Test; Dietary Supplement: Ethanol; Dietary Supplement: Lipid Emulsion; Other: Normal Saline
The order of metabolic visits: 1. Normal saline, 2. Ethanol, 3. Lipid emulsionExperimentalNot described
Receives: Diagnostic Test: 13C-α-Ketoisocaproic Acid Breath Test; Dietary Supplement: Ethanol; Dietary Supplement: Lipid Emulsion; Other: Normal Saline
The order of metabolic visits: 1.Lipid emulsion, 2.Normal saline, 3.EthanolExperimentalNot described
Receives: Diagnostic Test: 13C-α-Ketoisocaproic Acid Breath Test; Dietary Supplement: Ethanol; Dietary Supplement: Lipid Emulsion; Other: Normal Saline
The order of metabolic visits: 1.Lipid emulsion, 2.Ethanol, 3.Normal salineExperimentalNot described
Receives: Diagnostic Test: 13C-α-Ketoisocaproic Acid Breath Test; Dietary Supplement: Ethanol; Dietary Supplement: Lipid Emulsion; Other: Normal Saline
The order of metabolic visits: 1. Ethanol, 2. Normal saline, 3. Lipid emulsionExperimentalNot described
Receives: Diagnostic Test: 13C-α-Ketoisocaproic Acid Breath Test; Dietary Supplement: Ethanol; Dietary Supplement: Lipid Emulsion; Other: Normal Saline
The order of metabolic visits: 1. Ethanol, 2. Lipid emulsion, 3. Normal salineExperimentalNot described
Receives: Diagnostic Test: 13C-α-Ketoisocaproic Acid Breath Test; Dietary Supplement: Ethanol; Dietary Supplement: Lipid Emulsion; Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in arterialized plasma b-OHB to AcAc ratio

    Arterialized plasma b-OHB and AcAc concentrations

    Measured: From baseline to the end of treatment at 240 minutes

  2. Breath 13CO2 enrichment after ingesting 13C-alpha-ketoisocaproate

    Measured as area under the curve

    Measured: From baseline to the end of treatment at 330 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
The study protocol includes five clinical visits. At first visit, an informed consent will be obtained, followed by assessment of inclusion/exclusion criteria. Participants fulfilling the criteria will be enrolled in the study. At second visit, magnetic resonance studies will be performed to quantify liver fat content. Visits 3-5 consist of metabolic studies using the 13C-ketoisocaproate breath test and, in a random order, infusions of either a) saline alone, b) saline, a lipid emulsion and heparin or c) saline and ethanol.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559878
Sponsor's protocol ID
HUS/8748/2023
Acronym
ALPHA
Status last verified
Aug 2024
First submitted
12 Aug 2024
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to European Union GDPR regulations.

Questions about this trial

What is this clinical trial studying?

A study testing 13C-α-Ketoisocaproic Acid Breath Test, Ethanol and Lipid Emulsion in people with Non-alcoholic Fatty Liver Disease NAFLD, run by Helsinki University Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in arterialized plasma b-OHB to AcAc ratio (time frame: From baseline to the end of treatment at 240 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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