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Trigonelline Monohydrate for NAD+ Metabolism in Healthy Adults

AK
SR
Overseen ByStephanie Recker

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how trigonelline monohydrate affects NAD+ metabolism in generally healthy adults. NAD+ plays a crucial role in cellular energy production, and the study aims to determine how different doses of trigonelline influence its blood levels. Participants will receive either trigonelline monohydrate, a comparison treatment called nicotinamide mononucleotide (NMN), or a placebo for four weeks. Individuals who are healthy, non-smokers, and maintain stable dietary habits may be suitable candidates. The trial will also assess safety and how the body processes these supplements. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants a chance to be among the first to receive this new treatment.

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

Research has shown that trigonelline, a compound found in coffee and other plants, is generally safe for humans. Although few studies focus specifically on trigonelline monohydrate, similar compounds that increase NAD+ levels, such as NMN, have proven safe in early research. People taking NAD+ boosters, like NMN, usually experience few side effects. However, those with cancer concerns should exercise caution, as NAD+ boosters can influence cell growth.

Studies on nicotinamide mononucleotide (NMN) have demonstrated its safety for short-term use in humans, with only mild side effects like stomach discomfort. In this trial, NMN serves as a comparison to help assess the safety of trigonelline monohydrate.

In summary, while trigonelline monohydrate is still under investigation, related compounds have shown promising safety results, suggesting it might be safe for healthy adults.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Trigonelline Monohydrate and Nicotinamide Mononucleotide (NMN) because they offer a fresh approach to boosting NAD+ metabolism, which is crucial for energy production and cellular health. Unlike many existing supplements that rely on indirect methods to enhance NAD+ levels, Trigonelline Monohydrate is a direct precursor that might efficiently elevate NAD+ levels. NMN, on the other hand, is already known for its role in stimulating NAD+ production, but pairing it with Trigonelline Monohydrate could potentially amplify its effects. These treatments could offer a more potent and direct way to support cellular health compared to traditional options.

What evidence suggests that this trial's treatments could be effective for NAD+ metabolism?

This trial will compare the effects of Trigonelline Monohydrate and Nicotinamide Mononucleotide (NMN) on NAD+ metabolism in healthy adults. Research has shown that trigonelline could effectively boost NAD+, a molecule crucial for energy and cell health. In animal studies, trigonelline improved muscle strength and reduced tiredness as the animals aged, suggesting it might help increase NAD+ levels, which are vital for maintaining energy and reducing signs of aging. Similarly, NMN, another NAD+ booster tested in this trial, has been safely processed by the body and may help with age-related issues by raising NAD+ levels. Both treatments have shown potential benefits in early studies, but more research with humans is needed to confirm their effects.678910

Who Is on the Research Team?

GC

Gabriele Civiletto

Principal Investigator

dsm-firmenich Switzerland AG

Are You a Good Fit for This Trial?

This trial is for generally healthy adults aged 40 to 70 years. Participants should not have major health problems and must be able to safely take the study supplements as determined by the investigators.

Inclusion Criteria

Willing and able to comply with protocol including consuming standardized meals at Visit 2 and fasting overnight (minimum 8 hours) prior to applicable visits
I am between 40 and 70 years old.
Are able to consume study product capsules whole without chewing
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Exclusion Criteria

History of alcohol or substance abuse in 12 months prior to screening or use concerning to investigator
I have not lost or donated a significant amount of blood recently.
Individuals who are pregnant, intending to breastfeed, intending to conceive at consent or during study, or have positive pregnancy test
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive daily doses of trigonelline monohydrate, NMN, or placebo for 4 weeks to evaluate pharmacokinetics, pharmacodynamics, bioavailability, safety, and tolerability

4 weeks
Baseline/randomization visit (Day 1), 24-hour pharmacokinetic and safety visit (Day 2), Week 1 safety visit, end-of-study visit at Week 4

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)
  • Trigonelline Monohydrate

Trial Overview

The study tests different doses of trigonelline monohydrate, compares it with nicotinamide mononucleotide (NMN), and a placebo over 4 weeks. It looks at how these affect NAD+ levels in the blood, safety, and how the body processes these substances.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Trigonelline Monohydrate 680 mgExperimental Treatment1 Intervention
Group II: Trigonelline Monohydrate 510 mgExperimental Treatment1 Intervention
Group III: Trigonelline Monohydrate 340 mgExperimental Treatment1 Intervention
Group IV: Trigonelline Monohydrate 170 mgExperimental Treatment1 Intervention
Group V: Nicotinamide Mononucleotide (NMN) 600 mgActive Control1 Intervention
Group VI: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

dsm-firmenich Switzerland AG

Lead Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials
40
Recruited
2,400+

Citations

Baseline NAD + levels reported for different cells/tissues. ...

Results The results showed that Restorin NR significantly increased NAD+ levels above equivalent doses of NMN or NR chloride. Notably, Restorin NR at the low ...

Nicotinamide Adenine Dinucleotide (NAD) Metabolism as ...

NAD+ is an important metabolite in cell homeostasis that acts as an essential cofactor in oxidation–reduction (redox) reactions in various ...

Effects of NAD+ precursor supplementation on glucose and ...

Overall, supplementation with NAD + precursors improved triglycerides, total cholesterol, LDLc and HDLc but resulted in hyperglycemia, compared with placebo or ...

Trigonelline is an NAD+ precursor that improves muscle ...

Dietary trigonelline supplementation in male mice enhances muscle strength and prevents fatigue during ageing. Collectively, we identify ...

Nicotinamide Mononucleotide Is Safely Metabolized and ...

An increase in nicotinamide adenine dinucleotide (NAD+) levels alleviates age-related disease progression and promotes healthy life expectancy.

The Role of NAD+ in Regenerative Medicine - PMC - NIH

NAD+ plays a pivotal role in cellular metabolism and is a co-substrate for enzymes that play key roles in pathways that modify aging.

NAD (Nicotinamide Adenine Dinucleotide)

Metabolism: It supports chemical reactions that break down nutrients. Cell protection: NAD helps limit harmful byproducts that can build up when ...

Marketers say NAD+ pills and infusions can boost longevity ...

The risks Bhasin and other researchers say NAD+ precursor supplements like NR and NMN appear to be safe, based on what's seen in the clinical ...

NAD+ metabolism and its roles in cellular processes during ...

Several human clinical trials are ongoing to assess the safety and efficacy of NAD+ augmentation early-phase trials of short-term NR/NMN administration have ...

Nicotinamide adenine dinucleotide

In cellular metabolism, NAD is involved in redox reactions, carrying electrons from one reaction to another, so it is found in two forms: NAD + is an oxidizing ...