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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how niacin (vitamin B3) might assist individuals with non-alcoholic fatty liver disease (MASLD) by reducing liver fat and increasing fat storage in other tissues. Participants will receive either niacin or a placebo to determine niacin's effectiveness. Individuals aged 50 to 80 with MASLD, who have abdominal obesity and are post-menopausal, may be suitable candidates for this study. The trial seeks to determine if niacin can improve liver health in these individuals. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on liver health.

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.

Is there any evidence suggesting that niacin is likely to be safe for humans?

Research has shown that niacin, also known as vitamin B3, is likely safe for people. One study found that individuals with fatty liver disease who consumed more niacin had a lower risk of dying from any cause, suggesting a positive connection between niacin and overall health.

In lab studies, niacin reduced liver fat and inflammation in cells and animals, indicating potential benefits for liver health. These studies did not report serious side effects, suggesting that niacin is generally well-tolerated.

However, even though niacin is a vitamin, taking large amounts can cause side effects like skin flushing (redness and warmth) and an upset stomach. It is important to consult a doctor before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Non-Alcoholic Fatty Liver Disease (NAFLD), which often focus on lifestyle changes and medications like vitamin E or pioglitazone, niacin offers a fresh approach by utilizing a vitamin known for its lipid-altering effects. Researchers are excited about niacin because it may target the underlying metabolic issues associated with NAFLD by improving lipid profiles and reducing liver fat. Additionally, niacin's potential to be administered in a simple, once-daily dose makes it a convenient option that could enhance patient adherence compared to more complex treatment regimens.

What evidence suggests that niacin might be an effective treatment for non-alcoholic fatty liver disease?

Research has shown that niacin, or vitamin B3, might help reduce liver fat in individuals with non-alcoholic fatty liver disease (NAFLD). Studies have found that adding niacin to the diet can significantly lower liver fat and help prevent liver issues. Some research even suggests that higher niacin intake links to a lower risk of death from all causes, including heart disease, in people with NAFLD. In animal studies, niacin improved liver function by affecting certain biological processes. This trial will compare the effects of niacin with a placebo over a 12-week treatment phase. Overall, niacin appears promising for reducing liver fat and improving liver health. ^{1 3 4 5 6}

Who Is on the Research Team?

André Carpentier, MD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814504

Dietary Niacin Intake and Mortality in Nonalcoholic Fatty ... Findings In this cohort study of 4315 patients with NAFLD, higher dietary niacin intake was associated with lower risk of all-cause mortality.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10574350/

Association between Dietary Niacin Intake and ... Additionally, a lifestyle intervention study suggested that high dietary niacin intake may have a beneficial effect on reducing liver fat [13].

3. scientificarchives.com scientificarchives.com/article/pharmacologic-therapy-with-niacin-for-nonalcoholic-fatty-liver-disease-nafld-emerging-evidence

Pharmacologic Therapy with Niacin for Nonalcoholic Fatty ... We showed that the addition of niacin in the diet significantly reduced liver fat content and prevented hepatic steatosis [12]. Additional studies indicated ...

4. udshealth.com udshealth.com/blog/a-new-hope-for-fatty-liver-disease-vitamin-b3-shows-promise-in-early-study/

A New Hope for Fatty Liver Disease: Vitamin B3 Shows ... In treated mice, niacin reduced miR-93 levels, reactivated SIRT1, and reversed key markers of liver dysfunction. Because niacin is already used ...

5. medicalnewstoday.com medicalnewstoday.com/articles/dietary-vitamin-b3-may-help-lower-death-risk-in-nonalcoholic-fatty-liver-disease

NAFLD: Niacin, or vitamin B3, linked to lower death rates Recent research has shown that increased levels of niacin, or vitamin B3, could reduce overall death rates and death from cardiovascular disease ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38300619/

Dietary Niacin Intake and Mortality Among Individuals With ... Findings from this cohort study suggest that higher dietary niacin intake may be associated with lower risk of all-cause mortality among ...