Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
Stimulating Adipose Tissue Fatty Acid Disposal With Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
Université de Sherbrooke
36 participants
Apr 1, 2026
INTERVENTIONAL
Summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver. 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
Eligibility
Inclusion Criteria3
- aged 50 to 80 years;
- 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 Criteria9
- Presence of advanced fibrosis (i.e., ≥ F3 based on liver stiffness > 10kPa) using vibration-controlled transient elastography (FibroScan), serum ALT > 3 times the normal upper limit, or signs of portal hypertension \[106-109\].
- Other hepatic disease.
- Previous diagnosis of diabetes.
- Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
- Any contraindication to MRI.
- Previous intolerance or allergy to nicotinic acid.
- Having participated to a research study with exposure to radiation in the last two years before the start of the study.
- Being allergic to eggs
- Smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day.
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Interventions
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 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)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06843148