Niacin for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Statins, Niacin, Fibrates, others
Disqualifiers: Ischemic heart disease, Smokers, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
Adults who gain most of their excess weight in the abdominal area typically do not respond to things that "turn off" fat cells the same way as lean people. The researchers are trying to understand why fat tissue responds differently in people with different body types.
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 niacin safe for human use?
How does the drug niacin work for obesity?
Niacin is unique in obesity treatment because it increases adiponectin (a protein that helps regulate glucose levels and fatty acid breakdown) and decreases inflammation in fat tissue, which may help manage weight. Unlike other treatments, niacin also has a role in improving blood lipid levels and is known for its effects on increasing good cholesterol (HDL).678910
Research Team
Michael D Jensen, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
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 between 18 and 65 years old, can follow instructions, and am willing to eat specific meals for 3 days before the study.
See 5 more
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.
See 2 more
Trial Timeline
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
Treatment Details
Interventions
- Niacin (Other)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Upper body obesityExperimental Treatment1 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 weightExperimental Treatment1 Intervention
Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
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Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3427
Patients Recruited
3,221,000+
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Trials
2513
Patients Recruited
4,366,000+
References
[Niacin in therapy]. [2016]Niacin (nicotinic acid and nicotinamide) is a vitamin used as a source of the NAD+ and NADP+ coenzymes required for many metabolic processes. Its low dietary levels induce the development of pellagra. Niacin has been used for decades in the treatment of patients with disturbed lipid and lipoprotein metabolism, this being the main cause of atherosclerotic changes in cardiovascular diseases. It is still the most efficacious drug in terms of its ability to increase HDL cholesterol content accompanied by a decrease in all atherogenic lipoproteins (VLDL, LDL, and L(a)) as well as fatty acids and triglycerides. Niacin also increases adiponectin level, which might result in additional atheroprotection. There are studies confirming the beneficial action of niacin against migraine and hyperphosphatemia associated with renal failure, ethanol-induced neurodegeneration, and loss of beta-cell function in type 1 diabetes. Moreover, it augments plasma tryptophan concentrations in HIV-infected patients and thyroid radiosensitivity to 131I. Inhibition of the invasion of hepatoma cells has also been proven. However, it is necessary to point out that the currently applied niacin preparations might exhibit such side effects as cutaneous flushing, gastrointestinal disturbances, and hepatotoxicity, particularly during treatment with sustained-release niacin preparations. The recent discovery of the G-protein-coupled receptor GPR109A, which mediates the antilipolytic effects induced by nicotinic acid in adipocytes as well as cutaneous vasodilation, allows the development of new agents interacting with this receptor. In view of these observations, niacin therapy must be accompanied by control of the choice of niacin preparation and its dose in order to eliminate or at least limit its side effects.
Safety of extended-release niacin/laropiprant in patients with dyslipidemia. [2015]To evaluate the safety profile of extended-release niacin/laropiprant (ERN/LRPT), pooling data from studies in the clinical development program.
Niacin in cardiovascular prevention: mechanisms, efficacy, and safety. [2015]This review describes niacin's mechanism of action, efficacy in cardiovascular prevention, and safety.
[Efficacy and safety of immediate-release niacin in patients with ischemic cardiopathy. Experience of the Instituto Nacional de Cardiología "Ignacio Chávez"]. [2015]Primary and secondary prevention trials have demonstrated that niacin improves the lipid profile and reduces coronary morbidity and mortality.
The safety of niacin in the US Food and Drug Administration adverse event reporting database. [2015]Of currently approved drugs, niacin is the most effective in raising high-density lipoprotein cholesterol levels, either as monotherapy or in combination with other agents. The US Food and Drug Administration's (FDA) Adverse Event Reporting System provides 1 mechanism to evaluate the safety of niacin as it is used in common clinical practice. In this report, the authors review recent analyses of adverse events reported to the FDA demonstrating that the extended-release formulation of niacin (niacin-ER) has a significantly better safety profile compared with other niacin formulations and compares favorably with other commonly used lipid-altering drugs, including 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and fibrates. In addition, analyses of FDA adverse event reports of the pill combining lovastatin and niacin-ER suggest that the safety of combination therapy with niacin-ER and a statin is comparable with the safety of each of the drugs alone. These analyses should encourage the use of niacin-ER in patients at high risk for cardiovascular disease, as recommended by current national guidelines for cardiovascular prevention.
Prolonged-release nicotinic acid: a review of its use in the treatment of dyslipidaemia. [2018]Prolonged-release (PR) nicotinic acid (niacin) [Niaspan] is an oral, once-daily formulation of the lipid-modifying drug designed to produce less vasodilatory flushing than crystalline immediate-release (IR) nicotinic acid and less hepatotoxicity than previous sustained-release formulations of nicotinic acid.PR nicotinic acid appears to retain the same level of efficacy as crystalline IR nicotinic acid and be better tolerated than older nicotinic acid formulations. Nicotinic acid has beneficial effects on all traditional blood lipid and lipoprotein fractions and is the most effective agent for increasing high-density lipoprotein (HDL)-cholesterol (HDL-C) and reducing lipoprotein(a). The effects of PR nicotinic acid are often additive when used in combination with HMG-CoA reductase inhibitors (statins), making it a useful addition when lipid goals are not achieved with the usual statin monotherapy or when additional correction of a specific lipid abnormality is required. PR nicotinic acid also slows atherosclerotic progression and even appears to produce regression of atherosclerosis in patients on stable statin therapy. PR nicotinic acid is a logical drug choice for treating atherogenic dyslipidaemia commonly associated with type 2 diabetes mellitus and the metabolic syndrome, and has been shown to be effective in patients with diabetes without adversely affecting glycaemic control in the majority of patients. The incidence of vasodilatory flushing with PR nicotinic acid is lower than with IR nicotinic acid and it decreases substantially over time as tolerance develops. To date, there has been no clinically significant hepatotoxicity observed with PR nicotinic acid. Therefore, once-daily PR nicotinic acid appears to maximise the potential benefits of nicotinic acid, while minimising any historical tolerability or safety concerns.
Nicotinamide Protects Against Diet-Induced Body Weight Gain, Increases Energy Expenditure, and Induces White Adipose Tissue Beiging. [2021]Label="SCOPE">Interventions that boost NAD+ availability are of potential therapeutic interest for obesity treatment. The potential of nicotinamide (NAM), the amide form of vitamin B3 and a physiological precursor of nicotinamide adenine dinucleotide (NAD)+ , in preventing weight gain has not previously been studied in vivo. Other NAD+ precursors have been shown to decrease weight gain; however, their impact on adipose tissue is not addressed.
Niacin increases adiponectin and decreases adipose tissue inflammation in high fat diet-fed mice. [2021]To determine the effects of niacin on adiponectin and markers of adipose tissue inflammation in a mouse model of obesity.
Chronic niacin overload may be involved in the increased prevalence of obesity in US children. [2023]To investigate nicotinamide's action on glucose metabolism, and the association between niacin consumption and obesity prevalence.
Nicotinamide mononucleotide alters body composition and ameliorates metabolic disorders induced by a high-fat diet. [2023]Obesity is caused by an imbalance between calorie intake and energy expenditure, leading to excessive adipose tissue accumulation. Nicotinamide adenine dinucleotide (NAD+ ) is an important molecule in energy and signal transduction, and NAD+ supplementation therapy is a new treatment for obesity in recent years. Liver kinase B1 (LKB1) is an energy metabolism regulator. The relationship between NAD+ and LKB1 has only been studied in the heart and has not yet been reported in obesity. Nicotinamide mononucleotide (NMN), as a direct precursor of NAD+ , can effectively enhance the level of NAD+ . In the current study, we showed that NMN intervention altered body composition in obese mice, characterized by a reduction in fat mass and an increase in lean mass. NMN reversed high-fat diet-induced blood lipid levels then contributed to reducing hepatic steatosis. NMN also improved glucose tolerance and alleviated adipose tissue inflammation. Moreover, our data suggested that NMN supplementation may be depends on the NAD+ /SIRT6/LKB1 pathway to regulate brown adipose metabolism. These results provided new evidence for NMN in obesity treatment.