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Past News Items - May 2021


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In the News

Peer-reviewed Clinical Research Published On Nutritional Supplement ATP 360® Finds "Highly Significant" Reduction In Long-term Fatigue.

Kyowa Hakko Launches Clinically-Researched Paraprobiotic for Eye Health

Thorne HealthTech Partners with PreCon Health, Inc. to Launch First Supplements Formulated for Pre- & Post-Impact Brain Health

BCM-95® Curcumin Powerful Anti-Inflammatory for Knee Osteoarthritis

Parkinson’s, cancer, type 2 diabetes share a key element that drives disease




Released: May 2021


Peer-reviewed Clinical Research Published On Nutritional Supplement ATP 360® Finds "Highly Significant" Reduction In Long-term Fatigue.

Researched Nutritionals® announces the publication of peer-reviewed, clinical research on ATP 360®, a dietary nutritional supplement that utilizes multiple mechanisms of action to support patients' mitochondrial health and cellular energy production.*

 

LOS OLIVOS, Calif., May 3, 2021 /PRNewswire/ -- Researched Nutritionals®, a practitioner-exclusive dietary nutritional supplements company, announces the publication of peer-reviewed, clinical research on ATP 360®. The peer-reviewed research study illustrates the efficacy of this formulation in people experiencing long-term fatigue affecting their daily living. Key findings include[1]*:

  • "Reduction in long-term fatigue was rapid and highly significant"
  • "Participants had more energy [...] and became more active"
  • "Wellness scores improved, with highest effects on mental functioning, improved sleep, increased emotional wellness, and increased energy/vitality."
  • "Diastolic blood pressure was reduced."
  • "Serum levels of TNF-α were reduced."

The clinical research conducted on ATP 360® is available on PubMed (PMID: 33882028), originally published in Alternative Therapies (Alternative Therapies May/Jun 2021 Vol. 27 No. 3).

Researched Nutritionals® is committed to backing its formulations with peer-reviewed research. "The process of beginning with researched ingredients and then conducting clinical studies is at the heart of our mission," says CEO and founder Dennis Schoen. "These scientific studies strengthen the trust of our doctors and their patients because they can quantifiably see the science behind the benefits they're experiencing."

ATP 360® is a formulation developed by Dr. Debby Hamilton, MD, MPH. Dr. Hamilton, Director of Physician Education & Clinical Trials at Researched Nutritionals®, leads research and development of product formulations and coordinates the company's clinical trials and publication efforts. "When we develop a product, we start with a clear health objective that we want to address," says Dr. Hamilton. "We then select thoroughly-researched ingredients with specific mechanisms of action to create a targeted formulation. The process of publishing peer-reviewed clinical research allows us to show the efficacy of our products."

ATP 360® is the latest Researched Nutritionals® formulation to undergo the robust process of scientific evaluation. Other products featuring peer-reviewed, published clinical research include CytoQuel® for cytokine support and Tri-Fortify® Liposomal Glutathione, a powerful antioxidant that demonstrated significant intracellular absorption.*

About Researched Nutritionals®
Researched Nutritionals® was founded in 2006 by CEO Dennis Schoen with a mission to develop research-based formulations supported by ongoing clinical trials to demonstrate product efficacy. Researched Nutritionals® products focus on mitochondrial function, immune support, detoxification, and cytokine health. The company is dedicated to working directly with healthcare practitioners for their most challenging patient needs. Researched Nutritionals® is a leader within the practitioner-exclusive dietary supplement market, serving thousands of healthcare providers and their patients worldwide. The company combines a strong domestic and international sales team with a customer-centric corporate staff, providing an unparalleled customer experience.

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. Researched Nutritionals® and the Researched Nutritionals logo are registered trademarks of Researched Nutritionals, LLC. All rights reserved.

Researched Nutritionals®

[1]Hamilton, D., Jensen, G., Nutraceutical support of mitochondrial function associated with reduction of long-term fatigue and inflammation. Altern Ther Health Med. Alternative Therapies May/Jun 2021 Vol. 27 No. 3

Released: May 2021


Kyowa Hakko Launches Clinically-Researched Paraprobiotic for Eye Health

The EYEMUSE™-branded ingredient is supported by published studies, giving formulators a new option for products for consumers with digital device-related eye fatigue, from everyday professionals to gamers.

The ingredient is heat-killed Lactobacillus paracasei KW3110 and supports eye health by balancing the immune system, reducing inflammation, and supporting a proper response to stresses. Notably, the retina is made up of millions of immune cells.

“We are at a point in society where more and more adults are likely to face eye strain and fatigue from increasing reliance on technology and spending prolonged hours of the day staring at digital devices,” said Karen Todd, MBA, RD, Vice President of Global Brand Marketing at Kyowa Hakko USA Inc.

“This poses a real health and quality of life issue, so we are thrilled to be at the forefront of this scientific breakthrough that utilizes a novel mechanism of action that may help reduce digital stress related eye fatigue and other ocular discomforts.”

Science
Studies performed by Kyowa Hakko’s parent-company Kirin Holdings Co., Ltd. indicate that the heat-treated bacterial strain has anti-inflammatory effects and mitigates retinal pigment epithelium (RPE) cell damage caused by blue-light exposure.

A paper published in Nutrients in 2018 reported results of in vitro and in vivo human studies. The in vitro data indicated that EYEMUSE™ could protect human retinal pigment epithelial (ARPE-19) cells from the damaging effects of blue light.

The subsequent human study included 62 healthy Japanese volunteers who had experienced eye fatigue and were randomly assigned to receive either EYEMUSE™ or placebo for eight weeks. The data indicated that exposure to digital displays led to greater eye fatigue, but this fatigue was improved in the EYEMUSE™ group, compared to placebo.

Another study, published in the International Journal of Molecular Science, extended these findings by exploring the potential mechanism of action for the ingredient. Data from a mouse cell study showed that EYEMUSE™ led to significantly higher levels of the anti-inflammatory interleukin-10 (IL-10) compared with other lactic acid bacterium strains.

“We also showed that KW3110 suppressed human RPE [retinal pigment epithelial] cell senescence and the aberrant expression of tight junction molecules induced by chronic inflammatory stress signals from macrophages,” wrote the researchers.

In addition, the Kirin scientists performed a randomized, double-blind, placebo-controlled parallel-group study with 88 healthy adults aged between 35 and 50. The volunteers were randomly assigned to consumer supplements of EYEMUSE™ or placebo for eye weeks. Data from this trial indicated that EYEMUSE™ again improved measures of eye fatigue.

“Therefore, KW3110 might be a useful and safe tool to improve ocular disorders including eye fatigue,” concluded the researchers.

Daily professionals and gamers
Commenting on the target consumers, Todd said everyone can benefit from the ingredient. “We envision EYEMUSE™ to be geared toward the screen-glued multitaskers, young professionals who are always ‘on,’ and gamers, who are spending 14 hours a week playing video games, up from 12 hours a week in 2018,” she said.

The ingredient is non-GMO, vegetarian, and GRAS, according to Kyowa Hakko.

Source: Kyowa Hakko USA  (https://www.kyowa-usa.com/)

Released: May 2021


Thorne HealthTech Partners with PreCon Health, Inc. to Launch First Supplements Formulated for Pre- & Post-Impact Brain Health

Thorne HealthTech, a leader in developing the world's most innovative solutions for a personalized approach to health and wellbeing, today announced a strategic partnership with PreCon Health, Inc., a company focused on scientific discovery, innovation, and advancing safe and effective products that support healthy brain function, bringing to market the first multi-ingredient dietary supplements wformulated to support pre- and post-impact brain health. The partnership brings together Thorne's decades of industry leadership and expertise in nutritional supplements with PreCon Health's neurological, athletics and brain health expertise to address pre- and post-impact brain health. Brain health associated with physical impact is a significant public health concern in the United States and around the world.

"We are excited to be partnering with PreCon Health, Inc. to bring to market PreCon Health's pre-and post-impact brain health supplements, SynaQuell™ and SynaQuell+™, Thorne's first venture into brain health," said Paul Jacobson, CEO of Thorne HealthTech. "Their extensive neurological expertise coupled with Thorne HealthTech's testing and manufacturing capabilities, allow us to apply our unique insights and tools to provide solutions addressing impact-related brain health, a considerable public health concern in the U.S."

PreCon Health Inc's. patent pending formulations for SynaQuell™ and SynaQuell+™ leverage extensive research and target multiple pathological mechanisms known to contribute to the deleterious effects on impact-related brain health. SynaQuell™ is formulated to support healthy brain function, reduce inflammation, and promote cellular energy production and SynaQuell +™ is intended for the same purposes but following potential impact.

"Thorne's commitment to rigorous science and comprehensive testing from start to finish make them a perfect partner for PreCon Health. The partnership will leverage Thorne's commitment and ability to develop supplement formulas of the highest quality," said David Dodick, M.D., Professor of Neurology and Chair of Precon Health. "I am excited that PreCon Health and Thorne will be working together to address this significant need in the field of brain health, bringing to bear the data-driven, innovative health solutions that Thorne Healthtech is able to provide."

SynaQuell™ and SynaQuell+™ offer brain health support for both amateur and professional athletes, active-duty military, as well as millions of individuals who are subjected to physical impact every year in the United States. Both products will be manufactured and distributed by Thorne HealthTech. SynaQuell™ and SynaQuell+™ will be available through multiple channels, including Thorne.com, Amazon and via an extensive network of physician providers across the United States.

Additional information on SynaQuell™ and SynaQuell+™ will become available on April 19 at www.synaquell.com,  as well as www.thorne.com/synaquell.  

About Thorne HealthTech:
Thorne HealthTech is a leader in developing the world's most innovative solutions for a personalized approach to health and wellbeing. Thorne HealthTech is a science-driven wellness company that is utilizing testing and data to create improved product efficacy and deliver personalized solutions to consumers, health professionals and corporations. Thorne HealthTech's unique, vertically integrated brands, Thorne and Onegevity, provide insights and personalized data, products, and services that help individuals take a proactive and actionable approach to improving and maintaining their health over a lifetime. They have developed leading premium, high-quality nutritional supplements through their trusted Thorne brand, backed by rigorous science and comprehensive testing from start to finish. Through Thorne's merger with Onegevity, Thorne will offer health tests that are powered by Onegevity's Health Intelligence Platform, a proprietary, multi-omic platform, which uses AI and machine learning to map, integrate, and understand the billions of dynamic biological features that precisely describe the state of an individual's health.

Source: Thorne HealthTech  (https://www.thorne.com/)

Released: May 2021


BCM-95® Curcumin Powerful Anti-Inflammatory for Knee Osteoarthritis

Results of a new study reveal Arjuna Natural Pvt, Ltd.'s proprietary turmeric extract as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis (OA). The study demonstrated that the highly bioavailable compound was more effective in reducing inflammation. Osteoarthritis is a degenerative disease of the articular joints characterized by the breakdown of cartilage, joint lining, ligaments, and underlying bone. Common manifestations of osteoarthritis are stiffness and pain.

Led by Shuba Singhal, PhD, this randomized, controlled clinical study was conducted at the Department of Orthopedics of Lok Nayak Jai Prakash Hospital/Maulana Azad Medical College, New Delhi. Results were published in the journal Biomed Central BMC. For the study, 193 patients diagnosed with osteoarthritis of the knee were randomized to receive either turmeric extract (BCM-95®) as a 500 mg capsule two times daily, or a 650 mg tablet of paracetamol three times daily for six weeks.

Knee arthritis symptoms of pain, joint stiffness, and diminished physical function were evaluated using the Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC). After six weeks of treatment, responder analysis showed significant improvement in WOMAC scores across all parameters comparable to the paracetamol group, with 18% of the BCM-95 group reporting 50% improvement, and 3% of subjects noting 70% improvement.

These encouraging results were positively reflected in the BCM-95 group's serum inflammatory markers: CRP levels were reduced by 37.21%, and TNF-α levels were cut by an impressive 74.81%, indicating BCM-95 performed better than paracetamol.

The study was a follow up to an Arjuna study conducted over a year ago that demonstrated a positive link between its flagship high-bioavailable curcumin formulation and osteoarthritic care. "The goal of the current study was to build on the earlier studies to give a better clarity and specificity by including more markers and a better scoring methodology," explains Benny Antony PhD, Joint Managing Director for Arjuna. "The anti-arthritic effect of BCM-95 in osteoarthritis is attributed to its capability to modulate anti-inflammatory markers TNF and CRP."

Knee OA is the leading cause of disability and pain among adult and old age populations. An estimated 10 to 15% of all adults older than 60 years have some degree of OA, with prevalence higher among women than men. "This Study re-affirms the anti-arthritic effect of BCM-95 and provides renewed hope for millions to improve their quality of life", notes Nipen Lavingia, brand innovation advisor for Arjuna Natural based in Dallas, TX, USA. "It is no wonder that leading natural supplement brands supporting joint health, have chosen BCM-95."

"We are learning more about the mechanisms behind curcumin's anti-inflammatory effect which we believe is a result of its ability to inhibit pro-inflammatory signals, such as prostaglandins, leukotrienes, and cyclooxygenase-2. In addition, curcumin has been demonstrated to suppress several pro-inflammatory cytokines and mediators of their release, such as tumor necrosis factor-α (TNF-α), IL-1, IL-8, and nitric oxide synthase," explains Antony.

BCM-95's unique fusion of curcuminoids and turmerone-rich essential oil components overcomes curcumin's characteristic bioavailability hurdles due to its inherent high lipophilic nature. In a previous pilot crossover investigation in human volunteers, the relative bioavailability of Arjuna's formulation was shown to be nearly seven times higher than standard curcumin and scored considerably better than curcumin–lecithin–piperine formulations, as demonstrated by free curcumin levels detected in the blood.

SOURCE Arjuna Natural Ltd.  http://www.arjunanatural.com

Released: May 2021


Parkinson’s, cancer, type 2 diabetes share a key element that drives disease

When cells are stressed, chemical alarms go off, setting in motion a flurry of activity that protects the cell’s most important players. During the rush, a protein called Parkin hurries to protect the mitochondria, the power stations that generate energy for the cell. Now Salk researchers have discovered a direct link between a master sensor of cell stress and Parkin itself. The same pathway is also tied to type 2 diabetes and cancer, which could open a new avenue for treating all three diseases.

“Our findings represent the earliest step in Parkin’s alarm response that anyone’s ever found by a long shot. All the other known biochemical events happen at one hour; we’ve now found something that happens within five minutes,” says Professor Reuben Shaw, director of the NCI-designated Salk Cancer Center and senior author of the new work, detailed in Science Advances on April 7, 2021. “Decoding this major step in the way cells dispose of defective mitochondria has implications for a number of diseases.”

Parkin protein (green signal) is in a different part of the cell than the mitochondria (red signal) at time 0 (left image) but then co-localizes with the mitochondria after 60 minutes (right image).
Click here for a high-resolution image.
Credit: Salk Institute

Parkin’s job is to clear away mitochondria that have been damaged by cellular stress so that new ones can take their place, a process called mitophagy. However, Parkin is mutated in familial Parkinson’s disease, making the protein unable to clear away damaged mitochondria. While scientists have known for some time that Parkin somehow senses mitochondrial stress and initiates the process of mitophagy, no one understood exactly how Parkin was first sensing problems with the mitochondria—Parkin somehow knew to migrate to the mitochondria after mitochondrial damage, but there was no known signal to Parkin until after it arrived there.

Shaw’s lab, which is well known for their work in the fields of metabolism and cancer, spent years intensely researching how the cell regulates a more general process of cellular cleaning and recycling called autophagy. About ten years ago, they discovered that an enzyme called AMPK, which is highly sensitive to cellular stress of many kinds, including mitochondrial damage, controls autophagy by activating an enzyme called ULK1.

Following that discovery, Shaw and graduate student Portia Lombardo began searching for autophagy-related proteins directly activated by ULK1. They screened about 50 different proteins, expecting about 10 percent to fit. They were shocked when Parkin topped the list. Biochemical pathways are usually very convoluted, involving up to 50 participants, each activating the next. Finding that a process as important as mitophagy is initiated by only three participants—first AMPK, then ULK1, then Parkin—was so surprising that Shaw could scarcely believe it.

To confirm the findings were correct, the team used mass spectrometry to reveal precisely where ULK1 was attaching a phosphate group to Parkin. They found that it landed in a new region other researchers had recently found to be critical for Parkin activation but hadn’t known why. A postdoctoral fellow in Shaw’s lab, Chien-Min Hung, then did precise biochemical studies to prove each aspect of the timeline and delineated which proteins were doing what, and where. Shaw’s research now begins to explain this key first step in Parkin activation, which Shaw hypothesizes may serve as a “heads-up” signal from AMPK down the chain of command through ULK1 to Parkin to go check out the mitochondria after a first wave of incoming damage, and, if necessary, trigger destruction of those mitochondria that are too gravely damaged to regain function.

The findings have wide-ranging implications. AMPK, the central sensor of the cell’s metabolism, is itself activated by a tumor suppressor protein called LKB1 that is involved in a number of cancers, as established by Shaw in prior work, and it is activated by a type 2 diabetes drug called metformin.  Meanwhile, numerous studies show that diabetes patients taking metformin exhibit lower risks of both cancer and aging comorbidities. Indeed, metformin is currently being pursued as one of the first ever “anti-aging” therapeutics in clinical trials.

“The big takeaway for me is that metabolism and changes in the health of your mitochondria are critical in cancer, they’re critical in diabetes, and they’re critical in neurodegenerative diseases,” says Shaw, who holds the William R. Brody Chair. “Our finding says that a diabetes drug that activates AMPK, which we previously showed can suppress cancer, may also help restore function in patients with neurodegenerative disease. That’s because the general mechanisms that underpin the health of the cells in our bodies are way more integrated than anyone could have ever imagined.”

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