Past News Items - October 2022

In the News

Researchers identify a new protein that may contribute to Alzheimer's disease

‘Only Murders in the Building’ - NJ Labs Premiers Loyalty Program at SSW

Potential therapy derived from a banana protein works against SARS-CoV-2

Study Highlights Importance of Long-term Management of Hypertension

Essential Formulas Announces Publication of Scientific Study Demonstrating the Significant Anti-Fatigue Effect of Dr. Ohhira’s Probiotics

MENAQ7? K2 PROTECTED BY MATRIX TO LAUNCH AT SUPPLYSIDE WEST

Researchers identify a new protein that may contribute to Alzheimer's disease

Alzheimer’s disease (AD) currently has no cure and is predicted to affect over 100 million people worldwide by 2050. Ongoing research is focused on two key neurotoxic proteins: amyloid beta (Aβ) and tau. While these proteins have been shown to be associated with AD, for some people with the disease, the levels of Aβ and tau do not consistently explain or correlate with the severity of cognitive decline. To identify other proteins that may be directly involved with fundamental aspects of AD, like synaptic loss and neurodegeneration, investigators at Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, exposed laboratory neurons to human brain extracts from about 40 people who either had AD, were protected from AD despite having high Aβ and tau levels, or were protected from AD with little or no Aβ and tau in their brains. The researchers identified and validated ganglioside GM2 activator (GM2A) as a protein able to reduce neuronal firing and induce a loss of neurite integrity. These protein characteristics may contribute to the cause of AD, progression of the disease, or both.

“Our data helps identify a new and potentially important protein that may be associated with the pathogenesis of Alzheimer’s disease,” said senior author Tracy Young-Pearse, PhD, from the Department of Neurology. “Interestingly, GM2A has been previously implicated as a causative agent in a lysosomal storage disorder very similar to Tay-Sachs disease, another condition like AD that destroys neurons.”

Read more in Molecular Neurodegeneration.

‘Only Murders in the Building’ - NJ Labs Premiers Loyalty Program at SSW

Which attendees did it? Which attendees didn’t do it? It’s not a murder mystery, but a testing “Only Murders in the Building” challenge at SupplySide West that the team at NJ Labs plans to solve, with the help of conference attendees, to announce their new loyalty program for nutraceutical and dietary supplement manufacturers while highlighting the importance of partnering with a lab that will go beyond simply testing samples.

The on-site “testing investigation,” taking place in the Mandalay Bay Convention Center “building,” will be led by NJ Labs’ very own “Mabel Mora,” known to many in the industry as CEO, Sandra Lee. Conference attendees can stop by NJ Labs’ booth 4672 to pick up a social media scavenger hunt map that will lead individuals on their own testing investigation around the conference show floor “building” Nov. 2-3. Winners will be announced at 3 p.m. on Nov. 3 at the NJ Labs booth after a live taping of Lee’s “Going Beyond Testing” podcast at 2:30 p.m. Prizes include “Only Murders in the Building” swag bags and a $500 airline gift card grand prize (to the airline of your choice). A “whodunit” victory reception will follow with the winner announcements and “Gut Milk” shots and champagne will be served to all.

“Quality testing is critical to the manufacturing process,” said Lee. “We are an independent third-party testing lab with no bias, so in many ways our job is the independent investigator for the industry.”

NJ Labs is home to a diverse team of scientists who are dedicated to Quality and Accuracy in perfecting complex USP and FCC methods. Specializing in analytical chemistry and microbiology testing, NJ Labs provides services for the generic pharmaceutical, nutraceutical, dietary supplement, cosmetic and cannabis/CBD industries. Some of its services include: elemental and vitamin analysis; gas chromatography (GC); and antimicrobial effectiveness testing. NJ Labs is privately owned; FDA and DEA inspected; and certified for full-service contract analytical testing.

“Since testing is our core competency and is all we do, we understand the regulatory compliance environment to help manufacturers meet CGMP and CGLP processes and provide reporting results with comprehensive protocols that withstand FDA scrutiny,” said Lee. “We invest in the latest equipment, technology and methods so manufacturers don’t have to, and help companies avoid the costs of setting up an internal lab so they can focus on their own strengths and capabilities.”

NJ Labs’ “Going Beyond Testing” loyalty program provides manufacturers with a trusted partner that understands the regulatory environment and is able to provide transparency and accuracy to manufacturers. As an ISO/IEC 17025:2017 accredited contract laboratory that satisfies all testing requirements for selling on Amazon, NJ Labs is also in compliance with strict CGMP standards and is in a unique position to serve manufacturers as a laboratory registered with, and inspected by, the FDA and DEA. Membership to NJ Labs’ “Going Beyond Testing” loyalty program is free and includes special member pricing and discounts.

Don’t be a suspect! Join the whodunit testing challenge at SupplySide West, in Las Vegas at the Mandalay Bay Convention Center, NJ Labs booth 4672 starting Nov. 2 and celebrate the innocent at 3 p.m. on Nov. 3. It’s a testing adventure you won’t want to miss. Learn more about NJ Labs’ history and services at: https://njlabs.com. Also, join event sponsor, NJ Labs, at the What’s Up With Supps after party celebration on Nov. 3, and use promo code NJLabs10 to get $10 off the ticket price.

Potential therapy derived from a banana protein works against SARS-CoV-2

On January 13, 2020, a paper touting the creation of a possible therapy that could be used to fight all known strains of the flu was published online.

One week later, the first laboratory confirmed case of SARS-CoV-2 set off the two and a half year-long COVID-19 pandemic in the United States.

Interestingly, prior to the arrival of the virus that temporarily shut down their work, the international study team behind the influenza paper had also investigated the therapy of coronaviruses.

“At the time we thought MERS would be the big target, which we were worried about because of its 35% mortality rate,” said David Markovitz, M.D., professor of internal medicine, Division of Infectious Diseases at the University of Michigan Medical School. (MERS, or Middle Eastern Respiratory Syndrome, caused a brief outbreak in 2015 and resulted in 858 confirmed deaths.)

A paper in Cell Reports Medicine details the efficacy of H84T-BanLec against all known human-infecting coronaviruses, including MERS, the original SARS, and SARS-CoV2, including the omicron variant. Markovitz is joined by two senior authors, Peter Hinterdorfer, Ph.D., of the Johannes Kepler University Institute of Biophysics and Kwok-Yung Yuen, MBBS, M.D., of the University of Hong Kong. The first author on the paper is Jasper Fuk-Woo Chan, M.D., of the University of Hong Kong.

“When COVID-19 occurred, we of course wanted to study the therapy’s potential and discovered it was effective against every type of coronavirus, in vitro and in vivo,” Markovitz said. “Whether delivered systemically or through the nose in animal models, or prophylactically or therapeutically early on in the illness, it worked.”

H84T-BanLec is derived from a lectin (a carbohydrate-binding protein) isolated from banana fruit. It accomplishes its remarkable viral-blocking abilities by binding to high-mannose glycans, polysaccharides that are present on the surface of the viruses, but only very rarely on normal healthy human cells. After binding, the virus cannot enter cells to infect them.

Using atomic force microscopy and related methods, the team confirmed that H84T develops multiple strong bonds with the spike protein, which, said Markovitz, probably explains why it’s hard for a coronavirus to be resistant to the lectin.

Despite their anti-viral potential, lectins have traditionally been avoided as possible therapies because they are proteins that can stimulate the immune system in a potentially harmful way, explains Markovitz. However, H84T-BanLec has been modified to remove this effect and showed no detrimental effects in the animal models.

While several treatments for COVID-19 currently exist, including remdesivir, Paxlovid and monoclonal antibodies, they have varied levels of effectiveness, side effects and ease of use and many have proven less effective as SARS-CoV2 continues to evolve.

H84T-BanLec holds unique promise, according to the team, because it is effective against all coronavirus variants as well as influenza viruses. Markovitz and the team hope to see the therapy take the more difficult step from animal model to testing in humans. The team envisions a nasal spray or drops that can be used to prevent or treat coronavirus and influenza infections in seasonal and pandemic situations. They also hope to examine using H84T-BanLec against cancer—as cancer cells, like viruses, also have high mannose glycans on their surfaces.

Additional authors include Yoo Jin Oh, Shuofeng Yuan , Hin Chu , Man-Lung Yeung , Daniel Canena , Chris Chung-Sing Chan, Vincent Kwok-Man Poon, Chris ChunYiu Chan, Anna Jinxia Zhang, Jian-Piao Cai , Zi-Wei Ye , Lei Wen, Terrence Tsz-Tai Yuen, Kenn Ka-Heng Chik, Huiping Shuai, Yixin Wang, Yuxin Hou, Cuiting Luo, WanMui Chan, Zhenzhi Qin, Ko-Yung Sit, Wing-Kuk Au, Maureen Legendre, Rong Zhu, Lisa Hain , Hannah Seferovic, Robert Tampé, Kelvin Kai-Wang To, Kwok-Hung Chan, Dafydd Gareth Thomas, Miriam Klausberger, Cheng Xu , James J. Moon, Johannes Stadlmann, Josef M. Penninger, and Chris Oostenbrink. Thomas, Xu, Moon and Legendre are all from the University of Michigan.

Source: Michigan Medicine - University of Michigan

Study Highlights Importance of Long-term Management of Hypertension

In 2015, published findings from the landmark Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive blood pressure management reduced cardiovascular disease and lowered the risk of death. In 2019, results of the SPRINT MIND trial showed that lowering blood pressure also reduced the risk of mild cognitive impairment in older adults.

Now, researchers from Wake Forest University School of Medicine have shown that while intensive blood pressure control was beneficial to SPRINT participants’ health during the trial, the benefits for cardiovascular mortality went away after approximately two years when protocols for blood pressure management were no longer being followed.

The study findings are published online in JAMA Cardiology.

“We wanted to examine the long-term effect of SPRINT’s intensive treatment,” said Nicholas Pajewski, Ph.D., associate professor of biostatistics and data science at Wake Forest University School of Medicine and the study’s corresponding author. “The results are disappointing, but not surprising. If you have high blood pressure, controlling it is a lifelong commitment.”

The SPRINT trial, led by David Reboussin, Ph.D., professor of biostatistics and data science at Wake Forest University School of Medicine, confirmed that in adults 50 years and older with high blood pressure, targeting a systolic blood pressure of less than 120 millimeters of mercury (mm Hg) reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by 25%. The target also reduced the risk of death by 27%—as compared to a target systolic pressure of 140 mm Hg.

The study began in the fall of 2009 and included more than 9,300 participants ages 50 and older, recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. Participants were randomly assigned to a systolic blood pressure goal of either less than 120 mm HG (intensive treatment) or less than 140 mm HG (standard treatment). The National Institutes of Health (NIH) stopped the blood pressure intervention earlier than originally planned to quickly disseminate the significant preliminary results, resulting in a new set of guidelines for controlling blood pressure.

In the latest study, Pajewski and team linked participants to the National Death Index from 2016 to 2020, which added 4.5 years of follow-up for mortality after the conclusion of the trial. They also examined the electronic health records of trial participants for outpatient measurements of blood pressure.

“In addition to a diminishing benefit of intensive treatment on cardiovascular mortality, we saw a gradual increase in blood pressure for participants in the intensive treatment group, such that, four or five years after the trial, there no longer appeared to be a difference in systolic blood pressure between the groups,” Pajewski said. “The message here is clear. Sustained blood pressure control is necessary to continue to reduce the burden of fatal cardiovascular events.”

SPRINT was co-sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. The study was supported by NIH grants R01HL136679, R01AG055606 and R01AG065805.

Source: Wake Forest University School of Medicine

Essential Formulas Announces Publication of Scientific Study Demonstrating the Significant Anti-Fatigue Effect of Dr. Ohhira’s Probiotics

Essential Formulas Announces Publication of Scientific Study Demonstrating the Significant Anti-Fatigue Effect of Dr. Ohhira’s Probiotics Dallas, Tx- October 19, 2022 -Essential Formulas Incorporated is proud to announce the publication of the original research study, “The Anti-Fatigue Effect of Dr. Ohhira’s Probiotics (OM-X)” in the Journal of Functional Foods, October 2022, 105228.

Researched and authored by esteemed scientists Takeshi Kaneko, Akinobu Miyata, and Muneaki Takahata, the randomized, placebo-controlled, double-blind, comparative human study was designed to the same standards used in pharmaceutical drug trials.

STUDY DESIGN: 

This was a 12-week, double-blind, placebo-controlled trial. Forty healthy men and women between the ages of 40-59 were randomly divided into two groups. One group took three capsules of Dr. Ohhira's Probiotics once daily for 12 weeks, and the other group took three capsules of an identical-looking placebo for 12 weeks. Only healthy individuals participated in the study, as people with significant health problems were excluded.

HOW FATIGUE WAS MEASURED: 

The following two independent methods were used to measure levels of fatigue in this clinical trial:

1)Visual Analog Scale (VAS): This scale consists of a horizontal line 10 centimeters (3.94 inches) long. Participants are asked to place an 'x' on the line representing their fatigue level over the past seven days (left side = low fatigue, right side = high fatigue). The placement of the 'x' is then converted into a numerical score. A higher score corresponds with higher fatigue.

2)Chalder Fatigue Scale (CFS): This questionnaire consists of 14 questions relating to different aspects of physical and mental fatigue. The rating goes from 1 (no fatigue) to 4 (high level of fatigue). The higher the total score, the higher the overall level of fatigue.

RESULTS: 

All participants consuming Dr. Ohhira’s Probiotics registered significant reductions in fatigue on both the Visual Analog Scale and the Chalder Fatigue Scale. This finding provides robust scientific validation that taking Dr. Ohhira's Probiotics (3/day x 12 weeks) lowers fatigue levels and increases energy in healthy adults.

EXPLANATION/MECHANISM OF ACTION:

For several years, Dr. Ohhira's Probiotics have been produced by fermenting many plant-based foods with lactic acid bacteria (LAB). The final product contains over 500 postbiotic metabolites such as antioxidants, short-chain fatty acids, organic acids, vitamins, polyphenols, carotenoids, and more. It is well known that increased levels of free radicals can damage mitochondria. This, in turn, reduces the production of cellular energy (ATP), which results in higher levels of mental and physical exhaustion and fatigue. The antioxidant activity provided by the ingredients in Dr. Ohhira's Probiotics, especially the antioxidant activity of various postbiotic metabolites and polyphenols, explains the reduced fatigue levels in this recently published human scientific study.

"Over thirty years of supporting science has earned Dr. Ohhira's Probiotics the respect of scientific, academic, medical, and holistic health communities worldwide," said William Schoor, President of EFI. "We are proud that this new study is an added component in substantiating the trust and loyalty in this exceptional supplement."

* For a full copy of the research study, click here.  (https://essentialformulas.com/wp-content/uploads/2022/10/1-s2.0-S1756464622002985-main.pdf)

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Celebrating 22 Years of “Proven Probiotic Science,” Essential Formulas Incorporated (EFI) is the sole U.S. distributor of world-renowned microbiologist Dr. Iichiroh Ohhira’s award-winning probiotic supplements and skincare products. Always an innovator, EFI introduced Reg ’Activ® in 2015. Reg’Activ products contain Lactobacillus fermentum ME-3, a unique strain of probiotic bacteria that produces the "Master Antioxidant" glutathione. Essential Formulas is a family-owned and operated company whose mission is to market premium probiotics and other high-quality health-related products in the United States, Canada, and Mexico. 

MENAQ7? K2 PROTECTED BY MATRIX TO LAUNCH AT SUPPLYSIDE WEST

Gnosis by Lesaffre strengthens its position as the leading Vitamin K2 as MK-7 supplier by introducing SupplySide West attendees to MenaQ7? Matrix: a combination of its premier MenaQ7? Vitamin K2 as MK-7 brand delivered in its award-winning Matrix K2 enhanced protective technology.

Ensuring the stability of menaquinone ingredients can be as complex as the finished product formulations that brand owners are conceiving – research shows that moisture and mineral salts are critical variables for degradation, driving the need for a protective technology to shelter the menaquinone molecules during shelf life. Launched in December 2021, Matrix is the result of a proprietary technology that protects the particles of MK-7 with no coating, additives, or additional ingredients, providing a less cumbersome and more predictable formulation process for complex K2 products.

“Stability is a constant issue facing commercial partners who desire to create complex vitamin K2 formulations. that process is now more efficient because the Matrix technology embeds the K2 as MK7 particles in the product, thus leading to faster market introductions,” says Xavier Berger, Global Market Manager with Gnosis by Lesaffre. “Matrix was explicitly developed for Vitamin K2; it is not an adaptation of an existing technology previously utilized for other ingredients. Our team has worked extensively to ensure that our innovation was truly unique to the market, and, most importantly, that it would have a tremendous impact for those with a vision for what the market needs.” 

The technology is so groundbreaking that Nutrition Industry Executive recognized it with a First Place NIE Award for the Excipients/Non-Actives/Delivery Systems Category.

According to the scientific panel of experts judging the NIE Awards: “Solving the challenge of making vitamin K stable, especially in complex formulas, is something that should be appreciated by formulators and manufacturers … [Gnosis by Lesaffre] described in detail the chemical and physical properties of the K2 Matrix demonstrating good dispensability and bioavailability compared to other forms.”

Matrix enables cost-effective manufacturing, as improved stability and homogeneity reduce the need for overages, and clean label, as this natural protection requires the shortest list of ingredients with no additives.

What is truly exciting is the announcement that this technology will be applied to Gnosis by Lesaffre’s premier MenaQ7? Vitamin K2 as MK-7 brand.

“Gnosis by Lesaffre is a guarantor of quality in all that we do, which is why MenaQ7 is such an important piece of our portfolio. The MenaQ7 brand carries a stellar reputation built upon an unprecedented body of clinical evidence and patents, produced to the highest quality standards,” says Marc Philouze, General Manager with Gnosis by Lesaffre. “Applying the Matrix protective technology to MenaQ7 ensures a smoother process for formulators to bring any product concept they can conceive to life. More importantly, it ensures that consumers receive the clinically validated benefits they rightfully expect.”

MenaQ7? K2 Matrix will be a centerpiece of Gnosis by Lesaffre's SupplySide West booth 4652.

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About Gnosis by Lesaffre

Gnosis by Lesaffre harnesses the power of microorganisms and biotransformation processes like fermentation to cultivate nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and well-being. The team draws on its focused research and application capabilities to collaborate with nutraceutical and pharmaceutical brands to develop game-changing products for their customers.

About Lesaffre

A key global player in fermentation for more than a century, Lesaffre, with a 2,2 billion euro turnover, and established on all continents, counts 10,700 employees and more than 70 nationalities. On the strength of this experience and diversity, we work with customers, partners, and researchers to find ever more relevant answers to the needs of food, health, naturalness, and respect for our environment. Thus, every day, we explore and reveal the infinite potential of microorganisms.

To nourish 10 billion people, in a healthy way, in 2050 by making the most of our planet's resources is a major and unprecedented issue. We believe fermentation is one of the most promising answers to this challenge.

Lesaffre – Working together to better nourish and protect the planet.