Stimulating Fat Tissue Storage with Niacin to Reduce Fat Accumulation in the Liver.

Launched by UNIVERSITÉ DE SHERBROOKE · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a vitamin called niacin (also known as vitamin B3) can help reduce fat in the liver for people aged 50 to 80 who have a condition called Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). MASLD is often linked to obesity and type 2 diabetes and can lead to liver inflammation and damage. The main questions the researchers want to answer are whether niacin can help lower fat in the liver and increase the storage of healthy fat in other parts of the body.

To participate in this study, individuals must be between 50 and 80 years old, have MASLD, and be post-menopausal if they are women. Participants will be given either niacin or a placebo (a substance that looks like the drug but has no active ingredients) for up to 28 weeks. During this time, they will undergo tests to see how their body responds to the treatment. The study is not yet recruiting participants, but it's important to know that certain health conditions, like advanced liver disease or diabetes, may exclude someone from participating. This trial aims to find out more about how niacin could potentially help those dealing with liver fat issues.

Gender

ALL

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.