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UthPeak™: Validated for Safety and Efficacy

UthPeak™ stands alone as the only NMNH (Reduced NMN) supplement on the market with clinically validated safety and efficacy. Our dedication to consumer well-being has led us to conduct exhaustive toxicology tests across various matrices. These tests underscore its potential to support anti-aging, anti-fatigue, improve sleep quality, enhance brain function and promote cardiovascular health. Such clinical trials are pivotal in building consumer confidence, ensuring that UthPeak™ meets the highest standards of safety and efficacy.  Our transparent approach in validating UthPeak™'s safety underscores our commitment to not only meet but exceed industry standards.

Aim of Clinical Trials

The clinical trials for UthPeak™ NMNH are meticulously designed with a dual focus: 

 

Phase I clinical study seeks to rigorously evaluate its safety profile, ensuring that it meets the highest standards for consumer use without adverse effects. This involves a series of comprehensive assessments, including toxicological evaluations and dosage optimization. 

 

Building on these thorough safety measures, a Phase II clinical study was done, aimed to validate the efficacy of UthPeak™ in enhancing human health. This involves detailed investigations into how UthPeak™ influences key health markers and functions, particularly its role as a potent NAD+ booster. The trials seek to provide empirical evidence of UthPeak™'s potential benefits, such as its capacity to significantly boost energy levels, improve cardiovascular health, and offer liver protection.

 

The ultimate objectives of these clinical trials are multifaceted and far-reaching. By establishing UthPeak™ as a safe and effective health supplement, we aim to set a new benchmark in the NAD+ booster market. Beyond safety and efficacy, these trials are designed to contribute meaningful data to the broader scientific community, offering insights into how NMNH can play a pivotal role in promoting overall health and well-being. This research is not just about validating a product; it's about advancing our understanding of health supplementation and its impact on human physiology, potentially opening doors to new therapeutic possibilities and enhancing quality of life.

PreClinical Studies

The preclinical trials for UthPeak™ are designed to lay a solid foundation for clinical trials. The aim is to evaluate the compound's safety profile, such as its non-mutagenic nature and absence of acute oral toxicity, as well as its effect on chromosomal stability. The outcomes of these tests are crucial; they will directly influence the design and focus of subsequent clinical tests, ensuring a scientifically sound basis for further exploration of UthPeak™'s health benefits.

Pre-Clinical Studies

Jun.14, 2023

No mutagenicity

Bacterial reverse mutation test (Ames test)

Jun.15, 2023

No acute oral toxicity

Acute oral toxicity in rat

Jul. 25, 2023

Non-cytotoxic & Non-clastogenic

In vivo Chromosomal Aberration

test in Mouse

Aug. 31, 2023

Non-cytotoxic & Non-clastogenic

Bone Marrow In Vitro Mammalian

Cell Micronucleus test in CHO K1 cel1 line

Nov. 30, 2023

No toxcitiy, NOALE ≥ 1000mg/kg BW

Repeated dose 90 days oral

toxicity study in rats

UthPeak™ Clinical Trial Timeline

The forthcoming UthPeak™ clinical trials will concentrate on assessing NMNH’s potential in enhancing consumer-centric well-being factors, such as cardioprotection, energy enhancement, and liver protection.

2023

Toxicology Testing Completed

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In 2023, UthPeak™ completed a series of comprehensive toxicology tests. These tests were critical in assessing the safety of NMNH, examining aspects such as its non-mutagenicity, lack of acute oral toxicity, and potential for causing chromosomal aberrations, thereby setting a safe groundwork for human trials.

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2024

Phase I - Clinical Trial

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The Phase I clinical trial will primarily focus on determining the safety and tolerability of UthPeak™ in human subjects. This phase is crucial for establishing dosage ranges and identifying any potential side effects of this NAD+ booster, setting the stage for more extensive testing in Phase II.

2025

Phase II - Clinical Trial

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In the Phase II clinical trial set for 2025, the focus will shift towards evaluating the efficacy of UthPeak™. This phase will test the NMNH supplement's effectiveness in improving well-being factors like cardioprotection, energy enhancement, and liver protection in a larger group of participants, providing deeper insights into its health benefits.

Future Directions and Ongoing Research

The insights gained from UthPeak™'s ongoing and completed clinical studies are instrumental in shaping future research directions. They offer valuable data that not only reinforce the safety and efficacy of NMNH but also open new avenues for its application in health and wellness. Further studies are planned to explore these possibilities, continually advancing our understanding of NMNH's potential in human health.

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  • Is NAD approved by FDA?
    Currently, NAD and its precursors, like NMNH and NMN, fall under the category of dietary supplements. The Food and Drug Administration (FDA) doesn’t grant approval to dietary supplements in the same manner it does for pharmaceutical drugs. Instead, it monitors the market for any supplements that might pose safety concerns or make unsubstantiated health claims. Manufacturers are responsible for ensuring their products are safe and that any health claims are supported by evidence. While NAD supplements are available on the market, consumers should look for products from reputable sources to ensure quality and safety.
  • Is NMNH the same as NMN?
    NMNH (Reduced Nicotinamide Mononucleotide) and NMN (Nicotinamide Mononucleotide) are related but distinct compounds involved in the body's NAD+ biosynthesis pathway. NMNH is the reduced form of NMN, meaning it has undergone a bio-reduction reaction that changes its molecular structure. NMNH is metabolized through a different, NRK and NAMPT-independent, pathway, which potentially enhances NMNH's ability to increase NAD+ levels to a much higher extent and faster than NMN. While both are precursors to NAD+ and share the goal of boosting NAD+ levels within the body, their differences in chemical structures influence their stability and effectiveness in supplement forms.
  • Are there any dangers taking NAD supplements?
    Like with any supplement, there can be risks associated with taking NAD supplements, especially if taken inappropriately or in excessive amounts. Potential dangers could include interactions with medications, underlying health conditions, or side effects such as nausea, fatigue, and headaches in some individuals. However, when used under the guidance of a healthcare professional and within recommended dosages, NAD supplements are generally considered safe for most people. It's crucial to consult with a healthcare provider before starting any new supplement regimen.
  • How does the duration of NAD+ increase compare between NMNH and NMN?
    The duration of the NAD+ increase achieved by NMNH is longer compared to NMN. While NMN provides a boost in NAD+ levels, this tends to plateau relatively quickly. In contrast, NMNH not only elevates NAD+ levels rapidly but also sustains this elevation for a longer period, extending the duration of its beneficial effects.
  • Can NMNH be obtained through diet?
    Currently, NMNH is not typically obtained through diet. It is developed and administered as a supplement, primarily due to its specific molecular structure that is not readily available in dietary sources. As a specialized compound, NMNH is usually manufactured through a controlled process to ensure its efficacy and purity for supplemental use.
  • Is NMNH more effective in specific organs compared to NMN?
    Yes, NMNH appears to be more effective in specific organs compared to NMN. NMNH has shown a more significant impact on NAD+ levels in vital organs such as the liver, kidney, and brain. This indicates that NMNH could offer more comprehensive support for cellular health across these critical organs.
  • What are the implications of the difference between NMNH and NMN?
    The differences between NMNH and NMN have significant implications. NMNH's superior ability to increase and sustain higher NAD+ levels suggests it could be more effective in promoting cellular health and combating aging processes. This could lead to NMNH being preferred in therapeutic applications targeting age-related decline and diseases where cellular energy and repair mechanisms are crucial.
  • How does NMNH perform compared to NMN in increasing NAD+ levels?
    NMNH has been shown to outperform NMN in increasing NAD+ levels. Studies indicate that NMNH can raise NAD+ levels more significantly and rapidly than NMN. The enhanced molecular structure of NMNH allows for more efficient cellular uptake, leading to a more pronounced increase in NAD+ levels.
  • Can NMNH impact multiple tissues and organs?
    Indeed, NMNH can impact multiple tissues and organs. Its ability to increase NAD+ levels is not limited to a single type of tissue or organ. NMNH has been observed to enhance NAD+ levels in a variety of tissues, including the heart, brain and muscle, indicating its potential for widespread cellular support.
  • What makes UthPeak™ NMNH unique in the market?
    UthPeak™ NMNH boasts an advanced, patent-pending crystalline form, offering higher purity and stability compared to standard NMN supplements. This distinctive characteristic ensures it delivers enhanced and sustained NAD+ boosting effects, positioning UthPeak™ as a frontrunner in the NAD+ supplement market.
  • How long does the NAD+ boost from UthPeak™ NMNH last?
    UthPeak™ NMNH is notable for its longevity. It raises NAD+ levels for up to 6 hours and maintains them at a high level for about 24 hours. This extended duration surpasses that of many other NAD+ precursors, offering prolonged benefits for users.
  • How does UthPeak™ NMNH differ from other NAD+ precursors?
    UthPeak™ NMNH sets itself apart from other NAD+ precursors primarily through its exceptional potency. As a reduced form of nicotinamide mononucleotide (NMN), it can increase NAD+ levels up to ten times more effectively than similar compounds. The proprietary crystalline structure of UthPeak™ NMNH enhances its stability, ensuring it maintains its integrity and effectiveness in boosting NAD+ levels.
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Frequently Asked Questions About NAD Clinical Trials

CONTACT

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EffePharm Ltd.

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