RESEARCH AND RESOURCES
There is a lot of research and information on the internet concerning L-Serine, Peptides, Amino Acids, Vitamin C, Stem cells, as well as Menthol, Camphor, and Hylauronic Acid. We are offering links here to other web sites and directly to publications that can give you further information.
That said, we have attempted to link with medically reputable sites, standard medical associations or journals and not to advertising or marketing sites. Please contact us with any concerns or suggestions.
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One of Time Magazines 11 “Heroes of Medicine,” Dr. Paul Alan Cox discusses the latest findings concerning ALS and L-Serine in simple language in this TEDx talk: U.S. National Institutes of Health (NIH) Clinical Trial, “… These findings have led us to believe that high doses of L-serine could possibly stop the mis-incorporation of BMAA into brain proteins which in turn would slow or even abate the progression of ALS.” (From “detailed description”)
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The Non-Protein Amino Acid BMAA Is Misincorporated into Human Proteins in Place of l-Serine Causing Protein Misfolding and Aggregation ALS News Today – Environmental Toxin a Possible Cause of Symptoms of ALS, Alzheimer’s Disease with a link to the clinical paper.
Alzheimer’s Disease and Dementia
There are new studies and information about L-Serine and Alzheimer’s disease. Here is an article in the Washington Post as well as an article in the LA Times science section with links to the science.
Further information is identified in the article in Fortune Magazine. Along with this video …
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Information on the Phase 2 study testing L-serine in early Alzheimer's disease at the Dartmouth Hitchcock Medical Center on ClinicalTrials.gov.
Peripheral Neuropathy
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L-Serine Supplementation in Hereditary Sensory Neuropathy Type 1 (clinical trial)
Cancer Treatment - related Neuropathy treatment - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5545968/
Distinctive Role of Menthol in Pain & Analgesia - https://www.frontiersin.org/articles/10.3389/fnmol.2022.1006908/full
Fibromyalgia
Note that many people with Fibromyalgia also have nerve pain and symptoms that are found in peripheral neuropathy (see above), thus:
Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia. (From Harvard University and Massachusetts General Hospital.
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MayoClinic and Fibromyalgia - https://connect.mayoclinic.org/discussion/fibromyalgia-20d1d0/
Chronic Fatigue Syndrome
What is Hyaluronic Acid - Benefits
Effect of Novel Facial Serum containing Apple Stem Cells
Relationship between denatonium and capsaicin - the relationship between bitter taste -
Denatonium Capsaicinate provides an enhanced bitter and/or spicy, pungent flavor and may be used as an aversive agent, biocide, antifoulant and flavorant, for example. It is formed by reaction of a denatonium compound, Lidocaine or Lidocaine derivative with Capsaicin or a derivative thereof.
OTHER ARTICLES AND STUDIES
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Biemans EA, Verhoeven-Duif NM, Gerrits J et al. (2016) CSF d-serine concentrations are similar in Alzheimer's disease, other dementias, and elderly controls. Neurobiol Aging 42, 213-216.
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Hirabayashi Y, Furuya S (2008) Roles of l-serine and sphingolipid synthesis in brain development and neuronal survival. Prog Lipid Res 47, 188-203.
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Zhai PP, Xu LH, Yang JJ et al. (2015) Reduction of inflammatory responses by L-serine treatment leads to neuroprotection in mice after traumatic brain injury. Neuropharmacology 95, 1-11.
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Cox PA, Davis DA, Mash DC et al. (2016) Dietary exposure to an environmental toxin triggers neurofibrillary tangles and amyloid deposits in the brain. Proc Biol Sci283.
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Dunlop RA, Cox PA, Banack SA et al. (2013) The non-protein amino acid BMAA is misincorporated into human proteins in place of L-serine causing protein misfolding and aggregation. PLoS One 8, e75376.
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Bradley WG, Miller RX, Levine TD et al. (2017) Studies of Environmental Risk Factors in Amyotrophic Lateral Sclerosis (ALS) and a Phase I Clinical Trial of L-Serine. Neurotox Res.
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Levine TD, Miller RG, Bradley WG et al. (2017) Phase I clinical trial of safety of L-serine for ALS patients. Amyotroph Lateral Scler Frontotemporal Degener 18, 107-111.
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Stark AC (2017) Phase IIa L-serine Trial for eAD (LSPI-2). ClinicalTrials.gov.
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https://www.alzdiscovery.org/cognitive-vitality/ratings/l-serine
EVIDENCE
No clinical studies have tested whether L-serine can prevent age-related cognitive decline or dementia, though one trial is underway now. There are observational studies of L-serine levels in spinal fluid, blood, or in the brain and numerous preclinical studies. No clinical studies have tested whether L-serine can improve cognitive functions or prevent age-related cognitive decline.
FOR DEMENTIA PATIENTS
A phase 2 clinical trial testing the effects of L-serine in early-stage Alzheimer's patients is currently underway. There have been several studies examining cerebral spinal fluid and blood serum levels of L-serine in people with Alzheimer's, but no clear differences with healthy people have been found, nor any correlations between L-serine levels and cognitive functions Postmortem studies also showed that L-serine levels in the brain were comparable between Alzheimer's disease patients and healthy people.
Preclinical studies suggest L-serine may benefit those exposed to the neurotoxin beta-methylamino-L-alanine (BMAA). Our cells can mistake BMAA for L-serine and misincorporate it into proteins, which can lead to cell death and may increase biological markers of Alzheimer's. Laboratory studies indicate that L-serine may prevent misincorporation of BMAA and cell death. However, it is unclear whether L-serine affects biological markers of Alzheimer's in the absence of such neurotoxins.
We do not make any claims nor representations about the uses of L-Serine. We have no responsibility for any information offered at other sites, nor do we necessarily endorse their information or views.
FDA finalizes recommendations for studying absorption of active ingredients in topically-applied OTC monograph drugs.
Topical over-the-counter drug products applied to the skin, such as topical antiseptic or sunscreen, are often meant to be used repeatedly over time. People may wonder if these product are absorbed, and if so, what happens: for example, how much gets into the body or bloodstream, whether they’re safe to use, and whether there are any considerations for using these products in children or older individuals. While research indicates that some topical drugs can be absorbed into the body through the skin, this does not mean these drugs are unsafe, but this finding does call for further testing to determine the safety of repeated use and that once in the body the ingredient or product does not cause harm. The FDA has been working to better understand the level of this absorption and the resulting safety profiles for topical drugs,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Over the past several decades, collecting human absorption data to study potential risks of using a product according to the maximum levels of its directions for use has become a routine part of the application for new drugs before approval, and is also an important type of study for topical drug products marketed under the OTC drug monograph system. Today, in response to requests from industry for direction on the best way to collect these data for active ingredients seeking inclusion in an OTC monograph, we are issuing final guidance that provides recommendations on how to design and conduct these studies, known as Maximal Usage Trials, or MUsT trials. This information will help identify the need for further testing to assess potential safety concerns and help determine whether an adequate safety margin exists for an active ingredient to be included in a relevant OTC monograph.
This guidance, Maximal Usage Trials for Topically-Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations, finalizes a draft guidance on this topic that was issued in May 2018. MUsT is a standardized approach to assess the absorption of topical drugs into the body. Understanding systemic absorption of topical drugs consistent with maximal use of the product as specified by its labeling is a standard step in assuring their safety. The resulting absorption data can then be used with other safety testing to inform the overall benefit-risk evaluation of the drug or active ingredient. The guidance includes advice on, for example, how to choose the study population, noting that the study population should be representative of the population expected to use the product. It also provides recommendations for sample size, amount of the product to be applied, frequency of dosing and other important considerations, as well as recommendations about studying the active ingredient’s effects on specific subgroups of patients, such as children and the elderly.
Recent rulemakings and guidances on OTC antiseptics and sunscreens included MUsT studies among the list of studies being requested from industry in order to show whether an ingredient is generally recognized as safe and effective for use for the labeled indication.