Niacin for Obesity

Overseen By Pamela Reich

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must not be taking: Statins, Niacin, Fibrates, others

Disqualifiers: Ischemic heart disease, Smokers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the vitamin niacin (also known as nicotinic acid or Vitamin B3) affects fat tissue, with a focus on why individuals with excess weight around their midsection react differently to treatments. The trial divides participants into two groups: those with upper body obesity (extra weight around the belly) and those with a normal body weight. It aims to deepen understanding of how body shape impacts fat response. The trial seeks participants who struggle with weight gain primarily in their belly area and experience related issues in daily life, such as metabolic health concerns. As an Early Phase 1 trial, this research focuses on understanding how niacin works in people, offering participants the opportunity to be among the first to explore its effects on fat tissue.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications that can alter fat metabolism, such as high-dose fish oil, statins, niacin, fibrates, and others. If you are taking these, you may need to discontinue them for a specific period before joining the trial.

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

Research shows that niacin, or vitamin B3, is generally safe in normal amounts. However, high doses of prescription niacin can cause side effects. These may include liver issues, stomach ulcers, and changes in blood sugar levels, which could concern some individuals. It can also lead to muscle damage, low blood pressure, and irregular heartbeats.

While niacin is often used for its health benefits, such as lowering cholesterol, these side effects are more likely at higher doses. Participants should be aware of these potential risks when considering a clinical trial involving niacin. Consulting a healthcare provider before starting any new treatment is essential. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or even surgical interventions, niacin is being explored for its unique potential to impact fat cells differently. Niacin, a form of vitamin B3, is being studied for its ability to target fat cells in specific regions of the body, which could offer a more tailored approach to managing obesity. Researchers are excited about niacin because it may provide insights into how we can modify fat distribution, not just reduce overall weight, which could lead to more personalized and effective treatments.

What evidence suggests that Niacin might be an effective treatment for obesity?

Research shows that niacin, or vitamin B3, might influence body weight and fat distribution. Some studies have found that increased niacin intake can strengthen muscles and reduce fat, particularly around the belly. Another review found that niacin supplements slightly lowered body mass index (BMI), though the weight loss was minimal. Niacin also acts as an antioxidant, potentially protecting the body's cells from stress. However, some studies suggest excessive niacin could raise obesity risk, highlighting the need for balance. This trial will examine niacin's effects on different body types, focusing on individuals with upper body obesity and those with normal weight. While niacin appears promising, further research is necessary to understand its role in addressing obesity, especially for those with more upper body fat. ^{1 3 5 6 7}

Who Is on the Research Team?

Michael D Jensen, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This study is for men and women aged 18-65 who are overweight or obese, with a BMI of 29.0 - 40.0 kg/m2, especially those carrying extra weight around their abdomen. Participants must not have heart disease, high blood pressure that's uncontrolled by medication, be smokers, or take drugs affecting fat metabolism. They should also not be allergic to lidocaine or Niaspan.

Inclusion Criteria

No recent or current research participation in a study that involves an investigational drug

I am a man with most of my body fat around my waist.

I am not pregnant and follow the required birth control measures.

Exclusion Criteria

My blood pressure is still over 160/95 even with medication.

I am taking medication that affects how my body uses fats.

I am allergic to lidocaine, Niaspan, or indocyanine green.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Niacin to study fat cell response in different body regions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Niacin

Trial Overview The trial is investigating how niacin affects fat tissue in people with different body types, particularly focusing on adults who carry excess abdominal weight and may react differently to factors that usually 'turn off' fat cells.

How Is the Trial Designed?

Group I: Upper body obesity Experimental Treatment 1 Intervention

Subjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response.

Group II: Normal weight Experimental Treatment 1 Intervention

Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Niacin works by activating the GPR109A receptor, which helps reduce fat breakdown in fat cells and is also responsible for the flushing side effect, making it effective in cardiovascular prevention as shown in seven out of nine clinical trials involving various drug combinations.

While niacin can cause minor insulin resistance, it does not significantly worsen diabetes control or increase the risk of developing diabetes, and it is generally safe at lower doses, especially when combined with statins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niacin in cardiovascular prevention: mechanisms, efficacy, and safety. Guyton, JR.[2015]

In a study of 61 patients with ischemic heart disease and dyslipidemia, niacin significantly improved lipid profiles, reducing total cholesterol, LDL-cholesterol, and triglycerides while increasing HDL-cholesterol, particularly at a dose of 3.0 g/day.

Niacin was well tolerated by 62% of the patients, making it a safe and effective low-cost treatment option for managing dyslipidemia in patients with ischemic heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of immediate-release niacin in patients with ischemic cardiopathy. Experience of the Instituto Nacional de Cardiología "Ignacio Chávez"]. Morato Hernández, ML., Ichazo Cerro, MS., Alvarado Vega, AG., et al.[2015]

Niacin treatment in obese mice increased serum levels of adiponectin, an anti-inflammatory protein, by 21%, indicating its potential to reduce inflammation associated with obesity.

The study found that niacin reduced the expression of pro-inflammatory markers in adipose tissue, suggesting that it can help mitigate obesity-induced inflammation through mechanisms that depend on the niacin receptor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niacin increases adiponectin and decreases adipose tissue inflammation in high fat diet-fed mice. Wanders, D., Graff, EC., White, BD., et al.[2021]

Nicotinamide, when taken with glucose, significantly increased plasma hydrogen peroxide and insulin levels while lowering blood glucose levels, suggesting it may influence glucose metabolism positively in healthy individuals.

The study found a strong association between increased niacin consumption and rising obesity rates among US children, indicating that excessive niacin intake could contribute to obesity prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic niacin overload may be involved in the increased prevalence of obesity in US children. Li, D., Sun, WP., Zhou, YM., et al.[2023]

Nicotinamide (NAM), a form of vitamin B3, has been shown to prevent weight gain in mice by increasing overall energy expenditure and altering adipose tissue metabolism, particularly in white adipose tissue.

High-dose NAM treatment led to significant improvements in liver health, including reduced fat accumulation and inflammation, suggesting its potential as a therapeutic option for obesity and related metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Protects Against Diet-Induced Body Weight Gain, Increases Energy Expenditure, and Induces White Adipose Tissue Beiging. Méndez-Lara, KA., Rodríguez-Millán, E., Sebastián, D., et al.[2021]

Nicotinamide mononucleotide (NMN) supplementation in obese mice led to significant changes in body composition, including reduced fat mass and increased lean mass, indicating its potential as a treatment for obesity.

The study suggests that NMN may improve metabolic health by enhancing NAD+ levels, which activates the NAD+/SIRT6/LKB1 pathway, leading to better glucose tolerance and reduced inflammation in adipose tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide mononucleotide alters body composition and ameliorates metabolic disorders induced by a high-fat diet. Zhang, Y., Zhu, W., Wang, M., et al.[2023]

Niacin is the most effective approved drug for raising high-density lipoprotein (HDL) cholesterol levels, whether used alone or with other medications.

The extended-release formulation of niacin (niacin-ER) has a significantly better safety profile compared to other niacin formulations and is comparable in safety to commonly used lipid-altering drugs like statins, supporting its use in high-risk cardiovascular patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of niacin in the US Food and Drug Administration adverse event reporting database. Alsheikh-Ali, AA., Karas, RH.[2015]

Extended-release niacin/laropiprant (ERN/LRPT) demonstrated a favorable safety profile, with fewer flushing-related side effects compared to traditional niacin (ERN-NSP), based on data from 4747 participants across multiple studies lasting up to 52 weeks.

While there were slight increases in liver enzymes with ERN/LRPT, these were reversible and not linked to liver damage, indicating that ERN/LRPT can be safely used to enhance the lipid-modifying effects of niacin without significant adverse effects on muscle or liver health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of extended-release niacin/laropiprant in patients with dyslipidemia. McKenney, J., Bays, H., Koren, M., et al.[2015]

Prolonged-release (PR) nicotinic acid (Niaspan) is effective in improving lipid profiles, particularly in increasing HDL-cholesterol and reducing lipoprotein(a), while being better tolerated than older formulations with less risk of flushing and hepatotoxicity.

PR nicotinic acid can be safely used alongside statins to enhance lipid management in patients, including those with type 2 diabetes, without negatively impacting blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged-release nicotinic acid: a review of its use in the treatment of dyslipidaemia. McCormack, PL., Keating, GM.[2018]

Niacin is highly effective in increasing HDL cholesterol and decreasing harmful lipoproteins, making it a valuable treatment for lipid metabolism disorders and cardiovascular disease, but it can cause side effects like flushing and gastrointestinal issues.

The discovery of the GPR109A receptor, which mediates some of niacin's effects, opens the door for developing new treatments that could provide similar benefits with fewer side effects, highlighting the need for careful management of niacin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Niacin in therapy]. Nagalski, A., Bryła, J.[2016]

Citations

1. ods.od.nih.gov ods.od.nih.gov/factsheets/Niacin-HealthProfessional/

Niacin - Health Professional Fact Sheet Niacin (Vit B3) overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions here.

2. nature.com nature.com/articles/s41598-023-48566-8

Protective effects of niacin following high fat rich diet Niacin had long been understood as an antioxidant. There were reports that high fat diet (HFD) may cause psychological and physical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2874142/

Chronic niacin overload may be involved in the increased ... Excess niacin consumption may be a major factor in the increased obesity prevalence in US children. Keywords: Obesity, Diabetes, Niacin, Nicotinamide ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723000052

Increased Dietary Niacin Intake Improves Muscle Strength ... For every 1 mg/kg weight increase in daily niacin, total fat decreased by 0.061 kg/kg weight (95% CI −0.076 to −0.046 kg/kg weight) and trunk fat reduced by ...

5. jinfiniti.com jinfiniti.com/can-niacin-help-you-lose-weight/?srsltid=AfmBOor-UfAWp38nezAaKcqyzOL74Jxh9M2n_Kw20a6Pee1qESxsROAw

Can Niacin Help You Lose Weight? Niacin produces minimal weight loss of 1-2 pounds after months of supplementation but increases diabetes risk by 34% and causes liver ...

6. mayoclinic.org mayoclinic.org/drugs-supplements-niacin/art-20364984

Niacin Safety and side effects ... Experts believe niacin to be safe when taken by mouth in typical amounts. High doses of prescription niacin can cause:.

7. webmd.com webmd.com/diet/supplement-guide-niacin

Niacin (Vitamin B3): Benefits and Side Effects It can cause liver problems, stomach ulcers, changes to glucose levels, muscle damage, low blood pressure, heart rhythm changes, and other ...