Using niacin to shift fat into body fat and away from 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).

This study will test whether daily niacin can lower liver fat and increase storage of dietary fat in body fat in people age 50–80 with MASLD and abdominal obesity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Université de Sherbrooke (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Sherbrooke, Quebec)
• Trial ID: NCT06843148 on ClinicalTrials.gov

What this trial studies

This is a randomized crossover study in which participants receive 12 weeks of oral niacin and 12 weeks of placebo in random order with a 4-week washout between phases. Dosing escalates over three weeks to 750 mg daily, taken at the end of the largest meal, and outcomes are measured at the end of each treatment phase. Metabolic testing includes two intensive 9-hour visits per phase with a test meal, stable isotope tracers, PET with 18FTHA and 11C-palmitate, MRI, and blood sampling to measure hepatic and adipose fatty acid flux. The design includes paired visits without and with acute niacin given with the test meal to measure immediate effects on fatty acid trafficking.

Who should consider this trial

Good fit: Ideal candidates are men and postmenopausal women aged 50–80 with MASLD and abdominal obesity but without advanced fibrosis or prior diabetes.

Not a fit: People with advanced liver fibrosis, other chronic liver diseases, diagnosed diabetes, major cardiovascular or renal disease, contraindications to MRI, prior niacin intolerance, or recent research radiation exposure are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, niacin could reduce liver fat by redirecting dietary fatty acids into subcutaneous adipose tissue, potentially lowering risk of liver inflammation and progression.

How similar studies have performed: Prior studies have shown niacin acutely suppresses lipolysis and lowers circulating free fatty acids, but using chronic niacin to redirect dietary fat into adipose and reduce liver fat is a relatively novel, unproven approach.

Eligibility criteria

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.

Where this trial is running

Sherbrooke, Quebec

• Centre de recherche du CHUS — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: André Carpentier, MD — Université de Sherbrooke
• Study coordinator: Frédérique Frisch

Conditions Metabolic Dysfunction-associated Steatotic Liver Disease; Liver Fibrosis/NASH; Non-Alcoholic Steato-Hepatitis; Fatty liver; Niacin; vitamin B3; nicotinic acid