Nicotinamide Mononucleotide for Exercise Capacity in Aging

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scott Silveira

Must not be taking: NMN, NR, NAD+ supplements

Disqualifiers: Severe cardiovascular, respiratory, neurological, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special age-reversal therapy, EGA®, or regular nicotinamide mononucleotide (NMN, a supplement), can help older adults improve exercise endurance and possibly slow aging. The main focus is to measure how long participants can pedal on a stationary bike before fatigue sets in. The trial will also assess other health indicators, such as breathing capacity and energy levels. It seeks healthy adults aged 60 to 80 who can safely engage in moderate to intense cycling and have no major health issues. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on aging and exercise endurance.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not start any new medications during the study.

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

Studies have shown that Nicotinamide Mononucleotide (NMN) is safe for humans. Research indicates that healthy adults tolerate NMN well. In one study, participants took a daily dose of 1250 mg for up to 4 weeks without major side effects. Another study confirmed NMN's safety but found it did not significantly increase blood NAD levels, which are important for energy production in cells.

EGA® consists of compounds naturally found in the human body. Previous studies and real-world use have informed the current trial, suggesting it is familiar and safe. However, detailed information about EGA®'s safety in humans is limited.

Overall, both NMN and EGA® appear well-tolerated, but more safety data is available for NMN. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike current treatments for enhancing exercise capacity in aging, which often include lifestyle interventions and medications like beta-blockers or ACE inhibitors, Nicotinamide Mononucleotide (NMN) offers a unique approach. NMN is a precursor to NAD+, a crucial molecule in energy metabolism, potentially improving energy production in cells directly. Researchers are excited about NMN because it targets the aging process at a cellular level, aiming to enhance exercise capacity by boosting mitochondrial function, which is not addressed by traditional treatments. This novel mechanism could lead to improvements in physical performance and overall vitality in older adults.

What evidence suggests that this trial's treatments could be effective for improving exercise capacity in aging?

Research has shown that nicotinamide mononucleotide (NMN) can improve exercise performance. In studies with older mice, NMN increased exercise capacity by 56–80% and improved breathing during exercise, allowing them to continue longer before fatigue. NMN restores a molecule called NAD, which decreases with age and is crucial for energy production. These findings suggest that NMN could help older adults exercise more easily. In this trial, participants will receive NMN in different sequences with a placebo to evaluate its effects on exercise capacity in aging. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy older adults interested in potentially improving their exercise tolerance and slowing down aging. Participants should be free from serious health conditions that could affect the study's outcomes.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score of 26 or higher

Free from acute or uncontrolled chronic medical conditions that would pose a risk or interfere with study participation

I am between 60 and 80 years old.

Exclusion Criteria

Current substance abuse affecting study participation or adherence

I do not have severe heart problems like recent heart attacks or uncontrolled high blood pressure.

I do not have severe lung problems that stop me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either EGA or NMN for 4 weeks, followed by a washout period

4 weeks

Weekly assessments

Washout

Participants undergo a washout period to clear the effects of the first treatment

4 weeks

Treatment Period 2

Participants receive the alternate treatment (NMN or EGA) for 4 weeks

4 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotinamide Mononucleotide (NMN)

Trial Overview The trial is testing EGA®, a patented therapy, against conventional NMN supplementation to see which one better enhances exercise endurance and affects aging markers in healthy seniors. It's a blind test where neither participants nor researchers know who gets what treatment until the end.

How Is the Trial Designed?

Group I: Arm 4 - Placebo -> NMN Experimental Treatment 2 Interventions

Participants receive Placebo during Period 1, followed by NMN during Period 2 after a washout. Assigned Interventions: Placebo; NMN.

Group II: Arm 3 - NMN -> Placebo Experimental Treatment 2 Interventions

Participants receive Nicotinamide Mononucleotide (NMN) during Period 1, followed by Placebo during Period 2 after a washout. Assigned Interventions: NMN; Placebo.

Group III: Arm 2 - Placebo -> EGA Experimental Treatment 2 Interventions

Participants receive Placebo during Period 1, followed by EGA during Period 2 after a washout. Assigned Interventions: Placebo; EGA.

Group IV: Arm 1 - EGA -> Placebo Experimental Treatment 2 Interventions

Participants receive EGA during Period 1, followed by Placebo during Period 2 after a washout. Assigned Interventions: EGA; Placebo.

Who Is Running the Clinical Trial?

Scott Silveira

Lead Sponsor

Concordia University Chicago

Collaborator

EGACeutical

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9039735/

Nicotinamide mononucleotide (NMN) as an anti-aging health ... NMN supplementation could restore tissue NAD levels by fold change of 1 and overturn these processes which led to improved cognitive performance in aged mice.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07144527

Nicotinamide Mononucleotide Supplementation for ... The primary outcome is cycle ergometry constant work rate (CWR) exercise tolerance, measured as time to fatigue. Secondary outcomes include ...

3. nature.com nature.com/articles/s41514-022-00084-z

Chronic nicotinamide mononucleotide supplementation ... NMN dose-dependently increased the ventilatory threshold and improved aerobic capacity during exercise22.

4. sciencedirect.com sciencedirect.com/science/article/pii/S053155652300030X

Regular exercise effectively protects against the aging ... Two months of NMN supplementation (400 mg/kg/day, via drinking water) to 18-month-old mice increased their exercise performance by 56–80 % while lowering the ...

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

Advancements in NMN biotherapy and research updates in ... This suggests that NMN may be effective in mitigating the body's aging-related decline [15]. To elucidate the anti-aging potential of NMN, Mills ...

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

The Safety and Antiaging Effects of Nicotinamide ... This article integrates the safety and antiaging effects of NMN in preclinical animal studies and human clinical trials, particularly human clinical trials, to ...

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

Nicotinamide mononucleotide (NMN) as an anti-aging ... This article intends to provide an overview on the current knowledge on promises and safety concerns of NMN as an anti-aging health product.

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.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9735188/

The efficacy and safety of β-nicotinamide mononucleotide ... Another RCT found that the NMN supplementation was safe, but the increase of blood NAD concentration was not statistically significant with 300 ...