Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH, Non-Alcoholic Steato-Hepatitis (NASH)
In brief
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 20 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
Key facts
- Study ID
- NCT06843148
- Run by
- Université de Sherbrooke
- People needed
- 36
- Starts
- 2026-06-22
- Expected to finish
- 2030-07-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- aged 20 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;
You may not qualify if…
- Presence of advanced fibrosis using any of the following criteria 1.1 (i.e., ≥ F3 based on liver stiffness > 10kPa) using vibration-controlled transient elastography (FibroScan), 1.2 (Index for Liver Fibrosis > 2.67) using Fibrosis-4 (FIB-4) which is a calculated score based on age and a combination of lab tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and platelet count), 1.3 serum ALT > 3 times the normal upper limit, 1.4 or signs of portal hypertension. 2) Other hepatic disease. 4) Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
- 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.
- Being allergic to eggs 9) Smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day.
- Women who are pregnant or breastfeeding.
Where it is running
- Centre de recherche du CHUS — Sherbrooke, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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