Niacin for Non-Alcoholic Fatty Liver Disease

(AGL13 Trial)

Overseen By Frédérique Frisch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Advanced fibrosis, Other hepatic disease, Diabetes, Cardiovascular, others

Compensation: Varies

Number of Visits: 4

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug niacin for treating non-alcoholic fatty liver disease (NAFLD)?

Research suggests that niacin may help reduce liver fat and inflammation in NAFLD. In animal studies and a small clinical trial, niacin reduced liver fat and improved liver health markers. Additionally, higher dietary niacin intake was linked to a lower likelihood of NAFLD in a large population study. ^{1 2 3 4 5}

Is niacin safe for humans?

Niacin has been used for many years to treat high cholesterol, but it can cause liver problems, especially with high doses or time-release forms. Some people have experienced liver issues, so it's important to use it under medical supervision. ^{1 3 6 7 8}

How does the drug Niacin differ from other treatments for non-alcoholic fatty liver disease (NAFLD)?

Niacin, commonly known for its role in improving cholesterol levels, is being explored for NAFLD due to its potential to improve lipid profiles and insulin sensitivity, which are key factors in the disease. Unlike other treatments that focus on natural products or omega-3 fatty acids, Niacin's unique mechanism may offer a novel approach by targeting these metabolic pathways. ^{9 10 11 12 13}

What is the purpose of 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

Research Team

André Carpentier, MD

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

This trial is for individuals aged 50 to 80 with non-alcoholic fatty liver disease, often linked to obesity and type 2 diabetes. The study seeks participants who have not yet developed severe liver complications like cirrhosis.

Inclusion Criteria

I am between 50 and 80 years old.

I am post-menopausal.

I have been diagnosed with MASLD and have a fatty liver and abdominal obesity.

Exclusion Criteria

I have a liver condition.

Being allergic to eggs

Previous intolerance or allergy to nicotinic acid

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive niacin or placebo treatment for 12 weeks with a 3-week dose escalation

12 weeks

2 metabolic visits (in-person, 9 hours each)

Washout

A 4-week washout period between treatment phases

4 weeks

Treatment Phase 2

Participants receive the alternate treatment (niacin or placebo) for 12 weeks

12 weeks

2 metabolic visits (in-person, 9 hours each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Niacin

Trial Overview The study tests if Niacin (vitamin B3) can reduce fat in the liver compared to a placebo. Participants will receive either Niacin or a look-alike pill without active ingredients, aiming to understand its effect on fat storage in both the liver and white adipose tissue.

Participant Groups

Group I: Niacin group Active Control 1 Intervention

It will be a 12-week treatment phase. The treatment will be administered once daily, at the end of the largest meal.

Group II: Placebo group Placebo Group 1 Intervention

It will be a 12-week treatment phase. The placebo treatment will be administered once daily, at the end of the largest meal.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

Centre hospitalier universitaire de Québec- Université Laval

Collaborator

Trials

1

Recruited

40+

Findings from Research

Non-alcoholic fatty liver disease (NAFLD) is a widespread liver condition linked to obesity, characterized by fat accumulation in the liver, and currently has limited treatment options beyond diet and exercise.

Recent studies, including randomized controlled trials and animal models, suggest that certain natural products, like spirulina, garlic, and resveratrol, may effectively alleviate NAFLD symptoms, highlighting their potential as alternative therapeutic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It Is High Time Physicians Thought of Natural Products for Alleviating NAFLD. Is There Sufficient Evidence to Use Them? Tarantino, G., Balsano, C., Santini, SJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Niacin for treatment of nonalcoholic fatty liver disease (NAFLD): novel use for an old drug? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The Role of Vitamins in Non-Alcoholic Fatty Liver Disease: A Systematic Review. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Association between Dietary Niacin Intake and Nonalcoholic Fatty Liver Disease: NHANES 2003-2018. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The I148M PNPLA3 variant mitigates niacin beneficial effects: How the genetic screening in non-alcoholic fatty liver disease patients gains value. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Therapeutic role of niacin in the prevention and regression of hepatic steatosis in rat model of nonalcoholic fatty liver disease. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Hepatic toxicity of unmodified and time-release preparations of niacin. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Transient focal hepatic defects related to sustained-release niacin. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Niacin inhibits fat accumulation, oxidative stress, and inflammatory cytokine IL-8 in cultured hepatocytes: Impact on non-alcoholic fatty liver disease. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

It Is High Time Physicians Thought of Natural Products for Alleviating NAFLD. Is There Sufficient Evidence to Use Them? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Docosahexanoic Acid Plus Vitamin D Treatment Improves Features of NAFLD in Children with Serum Vitamin D Deficiency: Results from a Single Centre Trial. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Hepatoprotective Effect of Cranberry Nutraceutical Extract in Non-alcoholic Fatty Liver Model in Rats: Impact on Insulin Resistance and Nrf-2 Expression. [2022]

12. Iran pubmed.ncbi.nlm.nih.gov

Nigella sativa supplementation and non-alcoholic fatty liver disease: A systematic review of clinical trials. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Chia (Salvia hispanica)-supplemented diet ameliorates non-alcoholic fatty liver disease and its metabolic abnormalities in humans. [2021]