RECRUITINGINTERVENTIONAL

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).

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: 1. 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 \[106-109\]. 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: 1. 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 \[106-109\]. 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.

Treatments Being Tested

DRUG

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)

DRUG

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)

Locations (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, Canada