Nestlé Health Science initiates fully virtual study on ketogenic treatment for migraines

PRESS RELEASE

Nestlé Health Science initiates fully virtual study on ketogenic treatment for migraines

Lausanne, Switzerland November 18, 2021 — Nestlé Health Science (NHSc) has initiated a study looking into the effectiveness of a ketogenic nutritional supplement in reducing migraine attacks. The fully virtual study, taking place in Quebec, Canada, is investigating the effectiveness of a ketogenic nutritional supplement developed by Nestlé in reducing the number, intensity, and duration of migraines in people with episodic migraines.

This fully virtual study has been approved for conduct in the Canadian province of Quebec, with scientific and regulatory support from the Food & Nutrition Group within Intertek Assuris and is powered by a dedicated module within the Migraine Buddy app developed by Healint. The Clinical Research Unit at Nestlé R&D is managing the trial and the clinical operations activities are being executed by DIEX Recherche. This represents for Nestlé the first randomized clinical trial for central nervous system conditions to be conducted fully remotely, with no visits at the clinical site. [1]

The digital platform allows participants in the province of Quebec to be screened, recruited, and tracked in real-time across the five-month study, all from a single, easy-to-use, virtual interface. Moreover, the digital aspect reduces the risk of human errors associated with traditional paper-based records and increases the speed of data capture and cleaning.

“Migraines can be seriously incapacitating for sufferers, affecting every aspect of their lives,” said Hans-Juergen Woerle, Chief Medical and Scientific Officer for Nestlé Health Science. “We have seen promising evidence that by improving brain energy metabolism, for example with the use of ketones, the impact of migraines can be lessened.”  Nestlé Health Science is using a fully virtual study to improve patient experience, making trial participation more accessible and convenient, paving the way to future end-to-end digital clinical studies in medical nutrition.

“The COVID-19 pandemic has highlighted the need and benefit for clinical trials to go fully virtual; there are multiple cost efficiencies and benefits to a fully remote clinical trial which technology platforms like Migraine Buddy can facilitate,” said François Cadiou, CEO of Healint.

“We firmly believe that mobile health has the potential to revolutionize the way clinical studies are delivered” said Cadiou. “We are delighted that this partnership with Nestlé Health Science will allow clinical trials to proceed remotely and promote inclusion by extending the range of participants to beyond those residing near physical trial sites.”

Migraine is the sixth most disabling illness in the world, which affects around a billion people worldwide. More than half of all migraine sufferers are never diagnosed, while 15% of those diagnosed with migraine experience more than five attacks per month. Considering that 75% of the migraine population is female and that prevalence peaks between the ages for 18 and 44, the burden of migraine falls most heavily on women of childbearing age. Migraine is characterized by moderate to severe headache and is often accompanied by nausea, vomiting and photophobia.[2] It has detrimental effects on daily activities, it reduces quality of life and impairs productivity with limited participation in professional, academic, and social settings.

 

About Nestlé Health Science

Nestlé Health Science is a leader in the science of nutrition and a globally managed business unit of Nestlé. We believe in empowering healthier lives through nutrition and are committed to redefining the management of health, offering an extensive portfolio of science-based active lifestyle nutrition, medical nutrition and pharmaceutical solutions. Our extensive research network, both within Nestlé’s R&D centers as well as with external partners, provides the foundation for products that can help people to live their healthiest lives. Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries. www.nestlehealthscience.com.  

 

About DIEX Recherche

DIEX Recherche is a rapidly growing clinical research company with five sites in the province of Quebec. They have more than 50 ongoing studies and more than 40 studies to come in various therapeutic areas, such as memory loss, cardiovascular disease, vaccine, women’s health, dermatology, liver disease and many more. For more information about the company, visit www.diex.ca.

 

About Healint

Healint Pte Ltd is a leading healthcare technology company that is transforming how patients manage chronic central nervous system (CNS) conditions and how companies conduct clinical trials. Leveraging the latest innovations in software, data science and user experience design, Healint puts healthcare in the hands of patients and empowers them to be active participants in the discovery of new treatments. Healint helps companies to conduct virtual studies, to increase the quality of the data collected by lowering the barriers of entry for qualified patients. The company’s first global program—the Migraine Buddy platform and its apps—has over three million engaged users. Find out more at www.healint.com 

 

About Intertek Assuris

The Food & Nutrition Group within Intertek Assuris is a global leader in delivering expert scientific, toxicological, and regulatory consulting services.  Our multi-disciplinary team of scientific and regulatory experts helps companies achieve regulatory approvals for their food and dietary supplement ingredients, as well as their health claims, globally. 

 

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For media inquiries:

Nestlé Health Science

Jacquelyn Campo  Jacquelyn.Campo@nestle.com

 

Diex

Stacey Keet skeet@diex.ca

 

[1] www.clinicaltrials.gov – study NCT05085483

 

[2] Migraine Facts – Migraine Research Foundation

PDF version : Press Release NHSc Migraine Study November 2021

Researching to find new treatments that will change the future of humanity to the power of 5!

To celebrate the opening of its fifth research site in Quebec, the Diex Research team announced the news via videoconference hosted by Ms. Suzie Talbot, President. She is thrilled to end the summer with good news. Her enthusiasm stems from the creation of a new site that will allow her team to offer advanced clinical studies to the population of the Mauricie region.

In April 2020, Diex Research opened the doors of its new centre in Joliette, less than two years later, the company is opening a new facility at 6500 Gène-H.-Kruger Blvd in Trois-Rivières. The company will have its own facilities within the Centre cardiovasculaire de la Mauricie, which will allow patients to have easy access to several areas of expertise under one roof and will also facilitate collaboration with the doctors working at the clinic. “The choice of Trois-Rivières was a strategic one for us, as it will be the central geographic location in relation to our four other research sites,” says Suzie.

Diex Research is a private research company dedicated to conducting Phase I to IV clinical trials in Quebec. In addition, it is one of Canada’s leading clinical research centres and cofounder of HyperCORE International, a network of highly experienced and award-winning clinical research sites working together to accelerate and advance research. The company now has over 65 employees involved in its success. Diex will be looking for employees with a variety of skills to fill positions in the new clinical research centre, including: research nurse, research coordinator and laboratory assistant. In addition, the company will also be seeking family physicians, as well as specialty physicians from all therapeutic areas to conduct new studies.

Providing new and safe treatments that will eventually reach the market is the goal of all companies in the clinical research field, and with over 15 years of experience and now a 5th site, Diex Research is putting all of its energy into achieving it. The new site in Trois-Rivières represents the continuity of the efforts invested over the years.

Trois-Rivières is the city in the province of Quebec with the most cases of cardiovascular disease and a very large expertise in cardiology. “More than 20% of the population of the Mauricie and Centre-du-Québec regions is suffering from cardiovascular disease, diabetes, hypertension or heart failure, which makes them an ideal location for a research clinic to conduct studies and offer new treatments to patients.”

– Suzie Talbot, President of Diex Research

 Support for SMEs

The Fonds d’aide aux entreprises privées et des sociétés de services de la ville de Trois-Rivières aims to support private and social economy businesses in their expansion or establishment projects. The objective is to stimulate the economy, diversification and job creation. Diex is one of the companies that has been supported with a $10,000 grant to help set up its new research centre.

Participating in a clinical study: a new opportunity for the Mauricie and Centre-du-Québec regions

If you are interested in a project, how does the process work? The first step is to explain the study over the phone. You will then meet with a member of the team who can answer your questions. Next comes the medical tests or exams. Finally, if you meet the selection criteria, you can begin the clinical study. You will receive medical supervision throughout the study.

Dr. Sia, one of the main founders of the Centre cardiovasculaire de la Mauricie, will collaborate on clinical research to improve the prognosis of patients in the region. “Today’s drugs are the result of intensive research in the past. To continue to innovate and find the best treatment for our cardiovascular patients, I believe that clinical research is the key to success. I am very proud of the collaboration with Diex for research in the cardiovascular field and I am confident that Diex will enable us to accomplish our mission and meet the needs of our patients.”

– Dr. Sia, Cardiologist at the Centre cardiovasculaire de la Mauricie

Finally, it is an opportunity for the residents of Trois-Rivières and surrounding areas to have access to innovative treatments provided by an extremely competent team, whose first principle is the safety and well-being of patients.

For more information on the upcoming studies: www.diex.ca

For the PDF format : Press_Release_Diex_Trois-Rivières_14SEP2021

Information:

Suzie Talbot

President

stalbot@diex.ca

Development of a new treatment for “fatty liver disease”

DIEX Research

Development of a new treatment

for “fatty liver disease”

 

Quebec City, 14-07-2021—DIEX Research, a world-class Quebec-based company that conducts high-quality clinical research, is currently involved in the development of an experimental treatment for “fatty liver disease,” or non-alcoholic fatty liver disease, which affects as many as one in five Canadians, including a growing number of children.

Thanks to DIEX’s expertise in the Quebec City area and the financial support of the pharmaceutical company Pfizer, sponsor of the study, DIEX has been able to put together a team of specialized professionals who will spend the next few months conducting in-depth research on this disease for which there is still no satisfactory treatment.

“This kind of study will completely change the way we treat the disease in the future,” says Dr. Pascale Chouinard, the study’s principal investigator and a gastroenterologist, FRCPC, with a subspecialty in hepatology.

The study is evaluating the efficacy of two experimental oral medications. A first molecule is either administered alone or the same molecule is co-administered with a second molecule. The efficacy of the drugs is then evaluated, in particular by liver biopsies (samples of the liver). This is the first study of its kind to be conducted. “We are in Phase II, says Dr. Chouinard. Phase I has shown promising preliminary results, which gives us great hope for the future.”

A Difficult Disease to Diagnose

A specific subset of non-alcoholic fatty liver disease, called non-alcoholic steatohepatitis or NASH, results from the accumulation of fat in the liver cells, usually due to overconsumption of sugars and fats. This accumulation of fat causes liver inflammation and liver damage, and eventually leads to cirrhosis, the final stage of the disease. And when the damage becomes too severe, the only solution is to perform a liver transplant.

NASH is also associated with an increased risk of cardiovascular disease and leads to a deterioration in the quality of life of individuals, from fatigue to severe clinical symptoms. This is why it is important to treat it as early as possible.

The problem is that NASH is a silent disease and is most often diagnosed too late. “First of all, it doesn’t cause any specific signs or symptoms,” explains Dr. Chouinard. When the first signs appear, it is often too late, the disease is well established. The first signs are fatigue, jaundice, edema or digestive bleeding. “Blood tests and medical imaging can identify liver abnormalities,” says the gastroenterologist.


But these tests are not enough to make a diagnosis. The only effective way to detect the disease is a liver biopsy.

Canada’s First Clinical Research Study with Pfizer

To conduct the study, Pfizer provided DIEX with a FibroScan®, a device that quantifies liver fibrosis non-invasively, allowing for a painless examination. This device is generally only available in hospitals.

Thus, DIEX is the only clinical research centre in Canada, in collaboration with Pfizer, capable of conducting such research outside the hospital setting. The company relies on the expertise of its team of seasoned professionals, its scientific rigour and its creativity. Well-equipped to meet the challenges of developing new solutions for various diseases, DIEX is also currently conducting several other innovative studies, including the development of a plant-based vaccine against COVID-19 for the pharmaceutical company Medicago.

Opportunity to participate in the clinical study

Anyone with liver disease may be eligible to participate in this study conducted by DIEX.


 Interested individuals will be assessed by telephone by a recruitment specialist. If successful, they may then go through a screening process to determine eligibility for the clinical study.

The company is located at 205 Montmagny Street, Suite 102-103, Quebec City. Anyone interested can contact DIEX at 581-477-3439 or toll-free at 1-844-739-3439, or by email at info@diex.ca. For more information about the company: www.diex.ca.

Communiqué presse NASH- EN