Using niacin to shift fat into body fat and away from the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;

Exclusion Criteria:

1\) 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.

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.

10\) Women who are pregnant or breastfeeding.

Where it's running

• Centre de recherche du CHUS
  Sherbrooke, Quebec, Canada Recruiting

Study contacts

• Principal investigator: André Carpentier, MD — Université de Sherbrooke
• Study coordinator: Frédérique Frisch
• Email: frederique.frisch@usherbrooke.ca
• Phone: 1-819-346-1110

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• See if a Mediterranean-style lifestyle program helps MASLD patients improve liver health

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.