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
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
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.
2024
Phase I - Clinical Trial Completed
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
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.
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Where can I find the published clinical data on NMNH?We are currently conducting a Phase II clinical trial. Our findings from both Phase I and Phase II will be included in our upcoming paper submission. The publication date is yet to be determined; however, we will continue to update the results on our website and social media platforms. Contact us to stay informed.
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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.
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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.
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Are NMNH self-GRAS approved?UthPeak® NMNH (Reduced NMN) is the first NMNH brand to receive self-GRAS approval, meaning it has been assessed by a scientific expert committee for safety. It is now recognized as safe for use in selected conventional foods, dietary supplements, and medical foods.
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How do NMNH and NMN affect NAD+ levels?NMNH (Reduced NMN) and NMN both help increase NAD+ levels in the body, but they do so in slightly different ways. NMN directly boosts NAD+ through the salvage pathway, a process where existing NAD+ is recycled. In contrast, NMNH's reduced form may enable additional or more efficient pathways to elevate NAD+ levels. However, more research is needed to fully understand how NMNH is metabolized and how it compares to NMN in effectiveness.
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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.
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Are there any side effects of NMNH vs NMN?NMNH (reduced NMN) and NMN are generally regarded as safe, backed by findings from completed toxicology and clinical studies. As NAD+ supplements, they are typically safe for daily use. However, potential side effects may include nervousness, headaches, and fatigue. It is crucial to consult with a healthcare provider to establish the correct dosage and usage guidelines.
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What are the implications of the difference between NMNH and NMN?NMNH (Reduced NMN) and NMN are distinct chemical compounds, but both can effectively raise NAD+ levels. Our ongoing clinical studies indicate that NMNH (Reduced NMN) may play a significant role in reducing biological age markers and offering other potential advantages.
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Are NMNH and NMN the same thing?NMNH (Reduced NMN) and NMN (Nicotinamide Mononucleotide) are distinct chemical compounds. NMNH is the reduced form of NMN, differing in its chemical structure by the addition of a hydrogen atom.
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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.
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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.
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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.
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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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