Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
NCT ID: NCT06843148
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-09-30
2030-07-31
Brief Summary
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The goal of this mechanistic study is to investigate metabolic response in patients aged 50 to 80 years with non-alcoholic fatty liver disease, after niacin (vitamin B3) treatment.
The main questions it aims to answer are:
* Does Niacin lower the fat deposition in the liver?
* Does Niacin raise White Adipose Tissue storage of dietary fatty acids?
Researchers will compare Niacin to a placebo (a look-alike substance that contains no drug) to compare the metabolic response.
Duration of study per participant: Up to 28 weeks
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Detailed Description
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The two 12-week treatment phases will be performed in random order. The treatment will be administered once daily, at the end of the largest meal. There will be a 3-week dose escalation: from 250mg (the first week) to 750mg from week 3 onward.
The outcomes will be assessed at the end of each of these two treatment phases in all participants with metabolic visit A and B (i.e., a total of 4 metabolic visits).
Each metabolic visit will last 9 hours: it will be a test meal with perfusion of stable tracers, blood sampling, PET acquisitions using radiopharmaceuticals (18FTHA and 11C-palmitate) and MRI acquisitions.
The two visits A and B will be performed without and with acute administration of niacin with the test meal, respectively, to determine acute niacin-induced reduction in hepatic fatty acid flux.
The two visits will be performed at four to seven-day interval, in random order during the last week of each of the treatment phase.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo group
It will be a 12-week treatment phase. The placebo treatment will be administered once daily, at the end of the largest meal.
Placebo Oral Tablet
Placebo will be orally taken once daily with the largest meal. There will be a 3-week escalation period from 250 mg to 750 mg:
* Week 1: 250mg
* Week 2: 500mg
* Week 3 to Week 12: 750mg (3 x 250mg caplets)
Niacin group
It will be a 12-week treatment phase. The treatment will be administered once daily, at the end of the largest meal.
Niacin (250mg)
Niacin will be orally taken once daily with the largest meal. There will be a 3-week escalation period from 250 mg to 750 mg:
* Week 1: 250mg
* Week 2: 500mg
* Week 3 to Week 12: 750mg (3 x 250mg caplets)
Interventions
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Niacin (250mg)
Niacin will be orally taken once daily with the largest meal. There will be a 3-week escalation period from 250 mg to 750 mg:
* Week 1: 250mg
* Week 2: 500mg
* Week 3 to Week 12: 750mg (3 x 250mg caplets)
Placebo Oral Tablet
Placebo will be orally taken once daily with the largest meal. There will be a 3-week escalation period from 250 mg to 750 mg:
* Week 1: 250mg
* Week 2: 500mg
* Week 3 to Week 12: 750mg (3 x 250mg caplets)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed with MASLD, defined as the presence of liver steatosis + abdominal obesity (as defined by the International Diabetes Federation country/ethnic group-specific criteria;
* all women will be post-menopausal.
Exclusion Criteria
2. Other hepatic disease.
3. Previous diagnosis of diabetes.
4. Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
5. Any contraindication to MRI.
6. Previous intolerance or allergy to nicotinic acid.
7. Having participated to a research study with exposure to radiation in the last two years before the start of the study.
8. Being allergic to eggs
9. Smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day.
50 Years
80 Years
ALL
No
Sponsors
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Centre hospitalier universitaire de Québec- Université Laval
UNKNOWN
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Université de Sherbrooke
OTHER
Responsible Party
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André Carpentier
Tenure professor
Principal Investigators
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André Carpentier, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Centre de recherche du CHUS
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-5648
Identifier Type: -
Identifier Source: org_study_id
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