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 Research 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.
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 Stephanie Blum, Global Head of Translation Research 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.