NMN Supplementation for Metabolic Diseases

(VAN Trial)

No longer recruiting at 1 trial location

Overseen By Samuel Klein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Niacin, Nicotinamide, Vitamin B3

Disqualifiers: Women with menses, High caffeine, Unstable weight, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if NMN supplements can improve metabolic health, as animal studies have shown, but now tested on humans. Participants will take either NMN (a supplement) or a placebo for at least 16 weeks. The trial targets individuals with a higher body weight (BMI between 25.0 and 50.0) who have prediabetes, a condition where blood sugar levels are elevated but not yet in the diabetes range. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new health solutions.

Will I have to stop taking my current medications?

If you take niacin, nicotinamide, or other vitamin B3-related supplements, you will need to stop them for 3 weeks before the study and during the entire study period. The protocol does not specify about other medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NMN supplements are generally safe for people. One study found that taking 1250 mg of NMN daily for up to 4 weeks was safe and well-tolerated by healthy adults. Another study found that using NMN for 24 weeks did not cause any major safety issues, although it did not improve physical strength or walking speed.

While researchers continue to study NMN's safety, these findings suggest it is likely safe for humans. Prospective trial participants can find reassurance in the fact that NMN has not shown any major safety concerns so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about NMN supplementation for metabolic diseases because it targets a new mechanism by boosting levels of nicotinamide adenine dinucleotide (NAD+), a molecule involved in energy metabolism. Unlike standard treatments that often focus on controlling symptoms like blood sugar levels, NMN aims to improve cellular energy production, potentially addressing the root causes of metabolic dysfunction. This novel approach could offer more comprehensive benefits and improve overall metabolic health, making it a promising option compared to existing treatments.

What evidence suggests that NMN supplementation could be an effective treatment for metabolic diseases?

This trial will compare NMN supplementation with a placebo to evaluate its effects on metabolic diseases. Studies have shown that NMN can boost energy levels and physical activity. It also improves insulin sensitivity, helping the body use sugar more effectively. Research suggests that NMN increases NAD+, a molecule important for reducing age-related issues such as cellular stress and DNA damage. Some studies suggest that NMN might enhance exercise performance in older adults. Although NMN is generally considered safe, further research is needed to confirm its benefits for treating metabolic diseases. ^{4 5 6 7 8}

Who Is on the Research Team?

Samuel Klein, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with a BMI between 25.0-50.0 kg/m² who have prediabetes, indicated by certain blood sugar levels or insulin resistance scores. It's not open to women who are menstruating, people taking vitamin B3 supplements unless they stop them before and during the study, or those consuming more than two cups of coffee daily unless they can quit without withdrawal symptoms.

Inclusion Criteria

You have a body mass index (BMI) between 25 and 34.9.

I have prediabetes based on my glucose tolerance test or HbA1C levels.

Prediabetes defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7, or HOMA-IR ≥2.5.

Exclusion Criteria

I drink more than 2 cups of coffee or similar daily or get headaches if I stop.

Unstable weight (>3% change during the last 2 months before entering the study)

I am a woman who still has menstrual periods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NMN supplementation or placebo for at least 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Treatment

Trial Overview The study is testing if NMN (a compound that might improve metabolic functions) has positive effects on humans as it does in rodents. Participants will either receive NMN supplementation or a placebo to compare outcomes between the treated group and the control group.

How Is the Trial Designed?

Group I: NMN supplementation Experimental Treatment 1 Intervention

At least 16 weeks of NMN.

Group II: Placebo Placebo Group 1 Intervention

At least 16 weeks of placebo.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7238909/

The Science Behind NMN–A Stable, Reliable NAD ... NMN has been able to suppress age-associated weight gain, enhance energy metabolism and physical activity, improve insulin sensitivity, improve eye function, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323013595

The Safety and Antiaging Effects of Nicotinamide ... NMN supplementation increases NAD + concentration and could mitigate aging-related disorders such as oxidative stress, DNA damage, neurodegeneration, and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07144527

Nicotinamide Mononucleotide Supplementation for ... The study will assess safety and efficacy in improving exercise tolerance and modulating biomarkers of aging in healthy older adults. The ...

4. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05614-9

Advancements in NMN biotherapy and research updates in ... The results showed that supplementation with NMN for 24 weeks was safe but could not improve grip strength or walking speed [62]. A 12-week ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/10408398.2024.2387324

Full article: Efficacy of oral nicotinamide mononucleotide ... The objective of the review was to assess the effects of NMN supplementation on fasting glucose, triglycerides, total cholesterol, LDL-C, and HDL-C in adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721522/

The Safety and Antiaging Effects of Nicotinamide ... NMN supplementation increases NAD + concentration and could mitigate aging-related disorders such as oxidative stress, DNA damage, neurodegeneration, and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2090123221001491

Nicotinamide mononucleotide (NMN) as an anti-aging ... A few more human clinical trials are being conducted to evaluate the safety concerns of NMN supplementation and the outcomes are yet to be available.

8. nature.com nature.com/articles/s41598-022-18272-y

Safety evaluation of β-nicotinamide mononucleotide oral ... Our results indicate that β-NMN is safe and well-tolerated in healthy adult men and women an oral dose of 1250 mg once daily for up to 4 weeks.