We dedicate this November issue to the importance of clinical research in the field of natural health products. Also, we announce our first free webinar for 2020; it is going to be about substance-based medical devices under MDR.
We are happy to invite you to our next and first free webinar of 2020!
Substance-based medical devices under MDR – Steps you need to take!
by our experts Dr. Marlen Landschreiber and Dr. Solveigh Krusekopf
Date: 29th of January 2020 (Wednesday) Time: 15:00 – 15:45 (30 min talk and 15 min Q&A)
Save the date! More information will follow soon
Clinical Research News
Why invest in clinical research? Benefits of conducting research with an experienced CRO
In the last years, there has been an increasing demand from consumers to understand how a health-enhancing product works and provides its benefits. As technology evolves and consumers gain better understanding of medical knowledge, brands will benefit from scientifically and clinically substantiated products. As a consequence, food business operators (FBO) are being challenged to run clinical trials to support their products’ and/or ingredients’ benefits. However, contrary to the pharmaceutical industry, FBOs are generally less experienced when it comes to clinical research.
When the purpose of clinical research activity is the pursuit of health and/or nutritional claim applications, EU legislation and EFSA guidance documents detail how to perform clinical studies. Nonetheless, embarking on such clinical research activities in an efficient and regulatory-compliant manner can be a challenging endeavor. At a&r, we offer many types of studies for natural health products (food, nutraceuticals, herbals, substance-based medical devices), from marketing trials to trials with full regulatory compliance with e.g. FDA/EFSA. All studies are conducted according to the principles of Good Clinical Practice (GCP), and we provide flexible packages regarding monitoring, data management, statistics, project management etc., meaning that the client can decide which package better fits their needs.
Planning and budgeting costs for clinical trials is a difficult task. Thus, investing in a clinical research partner with deep background experience and understanding of the peculiarities of natural health products will pay off in the end. For example, being aware of the requirements of borderline products (e.g. food versus drug) is important for the study setup phase.
When comparing specialized clinical research organizations (CROs) with academic research organizations (AROs), what immediately jumps out is the price difference for a clinical investigation. AROs will definitely offer more agreeable prices; however, the experience and know-how of CROs enable them to better identify and understand the challenges when planning and/or executing a clinical trial and optimize strategies. CROs have the right infrastructure for efficient trial execution, data collection, and analysis at their disposal, as they provide professional clinical research services to clients on a daily basis.
Having strong experience and knowledge in the field of natural health products, a&r’s clinical experts are able to effectively estimate and optimize study budget and timelines by conducting risk assessments as early as possible, thereby influencing protocol design and avoiding amendments downstream. This will increase study performance predictability.
Study delays can play a major role in an environment where “time is money”. Paying special attention to enrolment times (recruiting and retaining subjects), to the inclusion of experienced investigational sites as well as to a careful selection of the study population will allow a successful trial completion.
Also key for the success of any clinical research project are communication and relationship management skills. At a&r, we foster a strong partnership and trust relationship with our sponsors in order to develop a shared vision. With this mindset, we increase the potential to complete projects better, faster, and more efficiently.
Did you know that a&r conducts infant clinical studies?
We have executed several growth and tolerance studies (e.g. with Human Milk Oligosaccharides (HMOs)) with hundreds of newborns (0 to 14 days old) from different EU countries, which also included complex microbiome analyses. Due to our carefully selected and experienced investigator network, we mastered timely recruitment. In addition, our expert regulatory team has also developed a deep understanding of infant nutrition regulations and guidelines for smooth market access.
If you would like to know more about our clinical research services, get in touch.
Adaptogens and valid health claims by integrating standardized stress tests with clinical trials
Euromonitor also reported that one of the five trends impacting consumers’ health and nutrition is stress and anxiety. With current lifestyle choices such as increased social media/digital exposure, fast and on-the-go lifestyles as well as the environmental and political environment, consumers are feeling more under pressure/tired, stressed, and anxious. This health category is the perfect indication for adaptogens.
Adaptogens have been used for centuries and are very common in Ayurvedic and traditional Chinese medicine. More recently, adaptogens are becoming increasingly popular in Western countries as consumers look for alternatives to traditional pharmaceutical treatments. Examples of adaptogens are rhodiola, holy basil, ashwagandha, schisandra, reishi, and turmeric.
In general terms, adaptogens are natural substances (herbs, roots, or mushrooms) that help the body adapt to stress. Based on a reflection paper by the European Medicines Agency’s (EMA), the term adaptogen or adaptogenic substances was defined as “substances that have the capacity to normalize body functions and strengthen systems compromised by stress. They are reported to have a protective effect on health against a wide variety of environmental assaults and emotional conditions.” EMA has established monographs for herbals that have adaptogenic properties, such as:
Rhodiola rosea used for the temporary relief of symptoms of stress, such as fatigue and sensation of weakness.
Eleutherococcus senticosus used for the relief of symptoms of asthenia (abnormal loss of strength and energy) such as tiredness and weakness.
The use of adaptogens by food/beverage companies has also increased in recent years. An example of such products is REBBL, with innovative adaptogen-infused beverages. However, health claims on these ingredients in food/food supplements are limited. To be able to make health claims on adaptogens, investing in clinical research in mandatory. The data could then be used to support an EFSA health claim application.
Interested in supporting your ingredient with clinical research?
a&r has established a collaboration with daacro, a CRO with particular expertise in the assessment of effects of substances on anxiety, depression, stress, and cognitive function.
Starting in 1993, the well-known “Trier Social Stress Test (TSST)” was introduced to the scientific community, and when it comes to inducing acute psychosocial stress under controlled laboratory conditions, the protocol has remained the gold standard until today. During the last 30 years, the methodology was applied and enlarged in basic research and applied product developments. TSST has been performed by many academic groups providing a large database on various outcomes activated or suppressed by an acute stressor. Therefore, these outcomes can serve well as endpoints in clinical trials to prove efficacy of an intervention. Extensions include modified protocols for certain age groups (e.g. children), better cost efficiency (group testing, virtual reality testing) or integrating certain assessments (e.g. cognitive tests).
The short (15 minutes) protocol has been applied thousands of times. It reliably activates both main stress systems, the autonomic nervous system (ANS) and the hypothalamus-pituitary-adrenal axis (HPA) and triggers an emotional and physiological response. TSST was further developed by daacro’s founders, and the team looks back on many years of experience. Additionally, daacro’s CRO was certified in November 2019 under ISO 9001:2015, strengthening the quality requirements on the TSST.
In line with cosmetic, nutritional, or pharmacological product developments, interventions and modes of action in stress, the various fields of measurement of TSST were successfully applied to skin & hair, perspiration, gut-brain-interaction, neuro- & immune-enhancers, learning & memory, sleep, anxiety & depression, etc.
Different standardized modules of the TSST allow the assessment of treatment effects on the following variables: (1) Psychological Response Measures (e.g. mood, perceived stress & anxiety, memory, attention); (2) Autonomic Response Measures (e.g. HR, BP, catecholamines, EDA, temperature); (3) Endocrine Response Measures (e.g. ACTH, serum & saliva cortisol, growth hormone, prolactin, DHEA); (4) Immune Response Measures (e.g. cytokines, leucocytes subsets); (5) Hematological Response Measures (e.g. hematocrit, hemoglobin); (6) Metabolic Response Measures (e.g. hemoconcentration, blood coagulation); (7) Gene Expression; (8) Psychomotor Response Measures (e.g. voice, dexterity, EMG). Further and depending on the choice of variables, this might also help understand underlying mechanisms. In sum, TSST is a well-accepted, precise, predictive and cost-efficient method to be integrated in clinical trials in a multitude of stress conditions, health impairments, and diseases associated with stress.
Stress management goes hand in hand with another food supplement category that is currently seeing growth – sleep. This clinical approach can be useful to support not only adaptogens but also other stress release ingredients in food supplements and even to support sleep quality.
Deerland probiotics & enzymes announces acquisition of Bifodan A/S
Deerland Probiotics & Enzymes, a US-based supplier of science-backed solutions for microbiome health, acquires Denmark-based company Bifodan A/S. Bifodan is a life science company specialized in developing, manufacturing and distributing unique probiotic product solutions as private label dietary supplements, medical devices and OTC drugs. This acquisition gives Deerland a bigger global presence in the field of enzyme, probiotic, and prebiotic health products.
STADA invests $660 Million USD in Takeda’s OTC portfolio in Russia/CIS to become a major player in these branded markets
Just the day after Stada Arzneimittel announced it was purchasing Czech consumer healthcare firm Walmark, the German company is now acquiring Takeda’s OTC portfolio in Russia, Georgia and the Commonwealth of Independent States (CIS) in a deal worth USD 660 million. The portfolio includes OTC vitamins and food supplements plus selected prescription pharmaceutical products. With this acquisition, STADA will become a major player in a large and structurally growing market.
Plant-based dairy-free company Mooala raises $8.3m in funding
Texas-based company Mooala, a dairy-free beverages producer, has raised $8.3 million in a Series A funding round lead by Sweat Equities, LLC. This funding will allow the 3 year old company to accelerate product development. Mooala’s best-known product is called Bananamilk, made from banana puree, sunflower seeds, sea salt, cinnamon and gellan gum.
ID#76 is a Traditional Herbal Medicinal Product (THMP) for the symptomatic relief of cough associated with cold. It is a ready-to-market combination of well-known expectorants available as easy-to-swallow tablets.
Expand your portfolio with ID#78, a food supplement enabling Vitamin D to be delivered buccally/sublingually!
Buccal/sublingual delivery not only allows fast absorption but also bypasses the first-pass metabolism. Bioavailability is clinically confirmed.
Dr. Inês RochaDirector of Business Development and Strategic Innovation
At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.
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