A Review of Clinical Studies in Elderly Populations
In 2018, people aged 65 years or over worldwide, outnumbered children under age five for the first time in history. By 2050, an estimated 1.5 billion people will be aged 65 or older. The healthy ageing industry is expected to become highly competitive and profitable. In functional food industries, differentiation is key. The first step of which is to prove the health benefits potentially associated with products. Human clinical studies are considered the gold standard method for the scientific substantiation of claims by the main health institutions and a powerful marketing and sales tool. However, there are some challenges and considerations when designing and conducting clinical trials involving elderly participants. Join us to unveil the secrets of human clinical studies within an ageing population.
Antimicrobial Potential of the Human Skin Microbiota
Join Dr. Julie O'Sullivan to understand her research on the area of the skin microbiome and how to translate those advancements into final cosmetic products thanks to the validation through human clinical trials. What kind of biomarkers and other considerations to take on board?
How the Microbiome and Diet Influence Immunity?
Learn about the relationship between the human microbiome, diet, and the immune system. Professor Liam O’Mahony & Gillian DunnGalvin will discuss the potential of different microbiome-based products (such as probiotics, prebiotics, or live therapeutics) to protect us against infections and associated inflammatory damage. Both theoretical and practical considerations will be presented from a clinical research perspective. Humankind faces a crisis of a communicable chronic disease that attacks the respiratory system, better known as Covid-19 or the Coronavirus. Due to the unprecedented arrival of this highly contagious disease, there has been a worldwide scramble to better understand the human immune system, its functions, and most importantly, what can we do to strengthen it.
Panel Discussion: Skin Microbiome from a Clinical Perspective
The pandemic has created a wellness-focused consumer. This has driven demand for clinically validated evidence behind products, extending to traditional beauty areas such as skincare. Including clinically proven ingredients will increase the success of a product. Join us on this live panel discussion with experts in academic research, in vitro & in vivo commercial research. The goal of this panel is to discuss cosmetic research and how new innovations could be brought to the market.
Brain-Gut-Microbiota Axis: A Novel Target for Drug Development
Join our Medical Director, Ted Dinan in this free-to-attend presentation. It is now becoming clear that bacteria might have a beneficial effect on mental health. Such bacteria may influence the capacity to deal with stress, reducing anxiety, perhaps positively impacting on mood, and are now called psychobiotics. Whether they are capable of acting like and in some circumstances, replacing antidepressants remains to be seen.
Exploring Human Food Clinical Trials and ICH GCP Standards
In highly competitive industries, differentiation is key. The alimentary and nutraceutical sector has faced multiple challenges within the last few years, particularly, in terms of the regulation around the marketing of functional foods and their associated health claims. With the market expecting to reach a value of $ 300,000 million by 2022, overcoming these hurdles is a must for those companies willing to compete for success. The first step for differentiation is to prove the health benefits potentially associated with functional foods, beverages, probiotics or medical foods. Randomised Controlled Trials (RCT’s) are considered the gold standard method for the scientific substantiation of claims by EFSA & FDA. Join us to unveil the secrets of RCT’s within the nutraceutical industry.
Functional Food Regulation: An Introduction to EFSA Health Claims
The European Food Safety Authority (EFSA) states that human intervention studies are ‘central’ to health claim substantiation and are also the ‘top of the hierarchy’ that informs decisions. Just how much data is necessary to deliver a positive health claim opinion and what can we learn from tracking past published opinions of EFSA’s NDA Panel? What are the key deliverables for any human intervention study or package of human studies?
Stress and Distress. Trial Design for Functional Foods
Functional Foods might support brain function, however, those health benefits should be validated through Human Clinical Trials. Join our Medical Director, Ted Dinan on this free-to-attend presentation and learn about how to design a clinical study on cognitive and mental health.
Panel Discussion: Bridging the gap between CBD science and regulation
In 2018, CBD sales in the United States were estimated at $534 million, according to the Hemp Business Journal. USA projections in 2025 are expected to reach an estimated $25 Billion. To many, CBD offers a variety of benefits when ingested, inhaled, or applied topically – with product marketing and advertising claims similarly ranging from calming effects to pain relief. Patient use fuels the research drive, which is rapidly increasing, and recent changes in the United States have paved the way for exciting new work. Both the safety and the potential therapeutic uses of these products need to be assessed for a range of indications. With the rapid expansion of new products, novel methods of use, and growing populations using these products for medical indications or for nonmedical use, regulatory restrictions are a major contributing factor to the limited data published addressing the most urgent questions on the potential effectiveness of products on the market for certain indications. Asa Waldstein joins the Atlantia team to discuss how to use clinical data for marketing purposes to overcome regulatory hurdles that many CBD companies are encountering when commercializing their innovations.Read more
Immune Clinical Studies, a Microbiome Approach
Join our immune research experts from University College Cork, to learn more about the relationship between the microbiome and the immune system, and its impact on respiratory health. We will review its implications when designing and conducting human clinical studies.Read more
Video Camera Endoscopy Technology in Probiotics Research
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are commonly used worldwide, both as prescription-only medicines and as “over-the-counter” preparations. However, low dose use of NSAIDS, is associated with gastrointestinal (GI) injury. Strategies to prevent GI complications associated with NSAID use included are generally associated with undesired side effects, whereas live bacteria formulated as probiotics may offer a safe alternative to prevent or at least decrease negative side effects of NSAIDS such as Aspirin. Given that deleterious compositional changes to the microbiota, in addition to direct effects on mucus and epithelial tissue, may increase the risk of NSAID-enteropathy, the sponsor of the present clinical trial hypothesised that an intervention targeting microbiome-host interactions may offer an attractive, preventative strategy. Their strain selection was based on the anti-inflammatory properties of certain bifidobacteria and experimental pre-clinical evidence for the role of bifidobacteria in NSAID-associated ulceration as well as unpublished pre-clinical screening data suggesting an efficacy potential of the specific strain belonging to this genus. In addition, another Bifidobacterium breve has been shown to express a pilus-associated protein (Tad E) in vivo, but not in vitro, which promotes colonic epithelial proliferation. It is described the development of a clinical model to assess the quantitative and time-resolved induction of small intestinal injury upon ASA administration.Read more
Food and Ingredient Development for Microbiome Modulation
Humankind faces a crisis of non-communicable chronic diseases that encompass pathologies such as obesity (and its co-morbidities), inflammatory bowel diseases, allergies, and autoimmune diseases. Microbiome alterations (dysbioses) induced through lifestyle and diet have been implicated in this development. There is tremendous potential for the targeted modulation and restoration of gut microbiota composition and functionality to combat chronic diseases.Read more
Panel Discussion: Clinical Trial Design for Microbiome-based Products
Our Clinical Research team meets together to respond to some of the main questions on how to design a human clinical study for microbiome based-products.Read more