The importance of clinical research: An interview with BioActor's in-house scientists
The importance of clinical research: An interview with BioActor’s in-house scientists
Interview
In the world of clinical research and scientific exploration, BioActor stands out as a leading company dedicated to the development of health ingredients. At the forefront of BioActor’s research and development (R&D) efforts are Sanne Ahles and Maria Imperatrice, two certified clinical research scientists who play vital roles in the BioActor’s R&D initiatives. In this interview, Sanne and Maria provide insights into their responsibilities, experiences, and the challenges they face in their pursuit of scientific advancement.
Could you introduce yourself and your role within BioActor?
Sanne: My name is Sanne Ahles and I am a clinical research scientist at BioActor. In addition, I am a PhD candidate at the Department of Nutrition and Movement Sciences at Maastricht University. I obtained my master’s degree in biomedical sciences after my internship at BioActor, after which I started working as a researcher.
Within BioActor, I am responsible for the research regarding our product Brainberry®, mainly focused on cognitive performance and vascular function. Over the years, I have designed, performed, analyzed, and reported various clinical studies, as well as written a systematic literature review.
Maria: My name is Maria Imperatrice and I also work as a clinical research scientist at BioActor. My research focus is Healthy Ageing and I’m currently performing two studies, Actiful2 and FEMMED, on two of our ingredients (Actiful® and Bonolive®) to evaluate their effect on exercise performance and postmenopausal symptoms, respectively.
I obtained my Bachelor Degree in Biology and my Master in Human Nutrition at the University “Federico II Di Napoli” in Italy, and my second master’s degree in Human Movement Sciences, with a specialisation in Sport and Nutrition, at Maastricht University.
At BioActor, we highly value clinical research because it plays a crucial role in providing evidence-based ingredients. What does clinical research entail and what do you like about it?
Sanne: Clinical research entails many different processes. This includes idea formation and initial literature searches, finding collaborations, obtaining ethics approval, practical work, data analyses, writing reports and papers, and communicating our results at national and international conferences.
Maria: A very interesting part for us is the ideation of the study. At BioActor we highly value innovation, which is why before starting a new clinical trial, we sit in brainstorming sessions with the R&D, marketing and sales teams to try to find white spaces in the current knowledge that can be of interest for the common public and different health domains. Once we find an interesting and never explored topic, the investigation can start.
Could you briefly take us through the process of a clinical trial?
Sanne: First, we initiate the idea formation process by brainstorming ideas that are relevant to customer questions or explore new areas of interest. Next, we perform literature searches to look for relevant papers, available data, and discover white space; topics that have not yet been researched.
Then we reach out to a collaborator, usually a professor at a University, to work with on developing a protocol for ethics review.
Maria: Once we obtain ethics approval, we dive into the practical phase of the clinical trial. This involves engaging with participants through visits where we collect data. This includes not only traditional data that we can extrapolate by collecting blood samples, but also performing tests to evaluate outcomes like reaction time, exercise capacity and mental flexibility.
It’s an interactive and rewarding experience that brings our research to life and allows us to better understand how our ingredients contribute to improving human health and develop evidence-based solutions. Afterwards, we analyze the data, draw conclusions, and share our findings through peer-reviewed publications. It’s a cool journey from start to finish!
Which of the above do you enjoy the most as a scientist?
Sanne: I enjoy collaborating with other companies or academic institutes! It’s such an incredible opportunity for us to broaden our knowledge and take our research to the next level. The energy and creativity that come from working with diverse teams is truly great.
Maria: The practical side of our work is always interesting! Collecting data means we get to perform visits with participants, and trust me, it’s never boring when you’re involved in a human study. The hands-on experience and the constant interaction with people make it such an exciting and fulfilling part of our job.
What is the biggest challenge in designing a study?
Sanne: In my opinion, the biggest challenge in designing a study is obtaining ethics approval, which is a rigorous and time-consuming process. We meticulously prepare documents explaining our research goals, methodology, and participant recruitment.
The ethical committee thoroughly reviews these documents, granting final approval for each aspect of our research.
Maria: I agree! Obtaining ethics approval is a significant challenge. However, this process is crucial for upholding ethical standards and protecting participant rights.
It also adds credibility to our research, fostering trust and allowing our findings to have a greater impact. Despite the challenges, navigating the ethics approval process is vital for conducting valuable and ethically sound research.
What is the best part of working at BioActor as a scientist?
Sanne & Maria: Being a scientist at BioActor is truly rewarding due to the chance to collaborate with a dynamic and passionate team of international colleagues. Within BioActor, we also see other aspects of the company besides R&D.
Our weekly company meetings allow us to really understand the bigger picture of the company and understand what each department entails. Consequently, we explore different facets of the company and gain valuable insights beyond our specific research and development focus.
BioActor: Using clinical science as the key to innovative ingredients
Sanne Ahles and Maria Imperatrice exemplify the passion and dedication that drive BioActor’s pursuit of finding new health effects of ingredients and advancing scientific innovation. From ideation to practical implementation, data analysis, and knowledge dissemination; they are pushing the boundaries of scientific knowledge and embracing the multidisciplinary nature of their work. Sanne and Maria contribute to BioActor’s mission of creating innovative and impactful solutions for a healthier life.
Cordiart® and Bonolive®obtained registration by the Malaysian National Pharmaceutical Regulatory Agency
Cordiart® and Bonolive®obtained registration by the Malaysian National Pharmaceutical Regulatory Agency
Press release
Both Cordiart® and Bonolive® obtained registration by the Malaysian National Pharmaceutical Regulatory Agency. Both finished capsule products of which one containing Cordiart® and the other Bonolive® are now officially registered and can be sold on the Malaysian market.
The Cordiart® and Bonolive® In Malaysia
Cordiart® and Bonolive® containing finished capsule products, named Smoozflo and Bonee Care, have been officially approved and registered in Malaysia by the National Pharmaceutical Regulatory Agency. Cordiart® finished capsule products are registered to be used for improving blood circulation under registration number MAL16110075TC. Bonolive® finished capsule products are registered to be used to strengthen bones and joints under registration number MAL16060038TC.
Both Cordiart® and Bonolive® have been clinically evaluated to have significant effects:
Two studies have shown that Cordiart® provides a triple protection of the arteries by improving arterial flexibility, reduces plaque formation, and lower arterial inflammation. The first study targeted patients with metabolic syndrome and impaired endothelial function, whilst the second study was looking at healthy overweight people. In both studies Cordiart® increased flow-mediated dilation compared to placebo. In addition the second study showed a reduction of the levels of adhesion molecules, responsible for plaque formation, and a reduction of the levels of inflammation markers, reflecting the inflammatory status of the arteries.
A 12-month double-blind, placebo-controlled study on a group of osteopenic patients consuming 250 mg/daily of Bonolive® showed a 32% significant increase in serum osteocalcin levels. This validates that Bonolive® prevents bone loss by strengthening bone metabolism and stimulating bone-building cell activity.
If you are interested in these products please feel free to contact our distributor for the Malaysian market, Membra Health, at info@membra.com.my.
About BioActor
BioActor, based in Maastricht, Netherlands, is a product development company that has developed a range of proprietary bioactive ingredients for the nutrition & healthcare industry. The company focuses on the development of innovative activities that address active living and healthy aging. The goal is to provide the nutrition & healthcare industry with science-based innovations that confer a real health benefit to the consumer.
Feel free to contact us via info@bioactor.com for more information on the possibilities Cordiart® and Bonolive® has to offer.
Further information can be found on: www.cordiart.com and www.bonolive.com
Clinical results published in a leading nutrition journal provide novel evidence supporting the beneficial effect of consumption of citrus flavanones on postprandial endothelial function.
Clinical results published in a leading nutrition journal provide novel evidence supporting the beneficial effect of consumption of citrus flavanones on postprandial endothelial function.
Maastricht, Netherlands, April 6, 2017
Press release
The British Journal of Nutrition has published results revealing that an acute, sole dose of citrus flavanones may counteract the transient decline in endothelial function, 7-hours postprandially. However, no effect was found 2-hours postprandially. This study corroborates findings from the latest clinical study on Cordiart®, a sweet orange extract. Moreover, it was shown that a repeated daily dose of standardized citrus flavanones may impart already 2-hours postprandially, a faster recovery in FMD response as compared to a sole dose.
The Clinical Benefits of Cordiart®
A recently published randomized, controlled, double-masked, crossover study (2017) has evaluated the acute impact (0-7 h) of flavanone-containing (mg) 240 ml beverages (orange juice: 128.9 mg; flavanone-rich orange juice: 272.1 mg; homogenized whole orange: 452.8 mg) on postprandial (Western diet/double meal with 81 g of fat) vascular function among middle-aged healthy men (30-65 years, N=28). Subjects had mild cardiometabolic risk factors with a baseline FMD (flow-mediated dilation) of 4.8 units and fasting lipids in the upper half of the normal range (TAG 0.8-3.2 mmol/l, total cholesterol 6.0-8.0 mmol/l) or BMI 25-32 kg/m2.
After 2-hours postprandially, there was no detected improvement in % FMD for all three interventions, despite differing flavanone concentrations. By 7-hours postprandially, all interventions were able to attenuate temporary impairments in FMD to that of baseline levels (7-hours post intake, P<0.05). This was suggested to be due to probable actions of citrus flavanone metabolites on nitric oxide.
Even though these results are promising, it can also be implied that an individual is exposed to endothelial dysfunction for up to 7-hours. By this time, it is common to have already consumed another meal (Western diet), reflecting that the majority of the day is spent in a postprandial state. This absence of a rapid postprandial effect may also be attributed to low flavanone bioavailability.
The article concludes that a daily intake of citrus flavanones may be an effective dietary strategy and ‘such temporary vascular changes repeated on a daily basis can critically impact long-term vascular health and overall chronic disease risk ’
Given the former, it’s important to have a rapid improvement in endothelial function postprandially. This was shown in a 6-week randomized, double-blind, placebo-controlled study that investigated the effects of a daily repeated intake of 500mg of Cordiart® on endothelial function. Already 2-hours after the consumption of a high-fat meal, 6-weeks of Cordiart® supplementation was shown to significantly increase and recover FMD (mean) by approximately 8.9% when compared to the mean baseline fasting level, in individuals with borderline chronic endothelial impairment (FMD≥3%). Therefore, Cordiart® may provide a faster recovery in FMD response as compared to a sole dose of non-standardized flavanones.
Moreover, orange juice is known to contain a high amount of sugar and is not standardized for active flavonoid content. Overall, Cordiart® provides a standardized dose of flavonoids, serving as an optimal solution for preserving endothelial function and supporting healthy blood flow.
About BioActor
BioActor, based in Maastricht, Netherlands, is a product development company that has developed a range of proprietary bioactive ingredients for the nutrition & healthcare industry. The company focuses on the development of innovative activities that address active living and healthy aging. The goal is to provide the nutrition & healthcare industry with science-based innovations that confer a real health benefit to the consumer.
Feel free to contact us via info@bioactor.com for more information on the possibilities Cordiart® has to offer.
Further information can be found on: www.cordiart.com
BioActor’s Research Director Sam Possemiers Introduces Cordiart® at MIS 2014: 21-22 May, Quimper- France
BioActor’s Research Director Sam Possemiers Introduces Cordiart® at MIS 2014: 21-22 May, Quimper- France
Press release
Cordiart® clinically shows high bioavailability and improvements in endothelial function proving to be a great rutinoside formulation for cardiovascular health. The results of the clinical trial will be discussed in more detail in the Molécules & Ingrédients Santé (MIS) by BioActor’s research director Dr. Sam Possemiers.
Cordiart® in the spotlight at Molécules & Ingrédients Santé
For the 5th time, Molécules & Ingrédients Santé (MIS) will gather during 2 days industrial scientists, university researchers as well as experts to focus on last advances and future prospects in terms of new active ingredients, clinical tests and legislation.
BioActor’s research director Dr. Sam Possemiers will give a lecture on BioActor’s innovative cardiovascular ingredient Cordiart®. Cordiart®, a specific rutinoside formulation for cardiovascular health, has shown strong clinical data on the improvement of endothelial function. Cordiart® stimulates the eNOS-enzyme which plays a pivotal role in the synthesis of Nitric Oxide, one of the most important regulators of vascular elasticity. Parties have completed a pharmacokinetics study showing the high bioavailability of Cordiart®.
MIS 2014 will take place in Quimper, capital city of Cornouaille with a high industrial, R&D and training potential in the fields of nutrition and marine ingredients. The health products field still represents a strong profitable industry with a US $11 billion global market and a 5% annual growth. In the same time, dietary supplements turnover is now exceeding US $50 billion in spite of recent regulatory limitations. In this context and because of stronger requirements of consumers regarding efficacy of ingredients, innovation remains the keystone of this high value-added economy.
About BioActor
BioActor, based in Maastricht, Netherlands, is a product development company that has developed a range of proprietary bioactive ingredients for the nutrition & healthcare industry. The company focuses on the development of innovative activities that address active living and healthy aging. The goal is to provide the nutrition & healthcare industry with science-based innovations that confer a real health benefit to the consumer.
Feel free to contact us via info@bioactor.com for more information on the possibilities Cordiart® has to offer.
Further information can be found on: www.Cordiart.com
BioActor receives EUROSTARS grant for the FlaMeS project “Flavonoids and metabolic syndrome”
BioActor receives EUROSTARS grant for the FlaMeS project “Flavonoids and metabolic syndrome”
Press release
BioActor leads the international FlaMeS-consortium to develop novel in-vitro cell technology and clinical validation of Cordiart® for the prevention of the metabolic syndrome. The FlaMeS consortium is a collaboration between two innovation driven SMEs, BioActor (Netherlands) and AdipoPhyt (France). The project will result in the development and clinical validation of novel 3-D cell assays for adipose tissue development and in the clinical validation of a proprietary citrus flavonoid extract for the improvement of glycaemic control and endothelial function.
The FlaMeS project
BioActor BV announced today that EUREKA has approved the FlaMeS project, submitted by BioActor and AdipoPhYt. The FlaMeS Consortium has two objectives: (1) validating novel 3-D cell-based assays to screen for effects of compounds on adipose tissue development, and (2) clinically test and validate effects of Cordiart®, a citrus peel extract, on markers associated with the metabolic syndrome.
Prevalence of obesity and the metabolic syndrome is rapidly increasing, affecting millions of people in Europe alone. Public health authorities have recognized the need for prevention of these chronic diseases. BioActor addresses this need by developing a unique, natural product for improved functioning of blood vessels, glycemic control and heart health: Cordiart®.
Cordiart® is a natural flavonoid citrus peel extract with optimized bioavailability. This ingredient commands a high content of natural bioactive flavonoids. A number of in-vivo and human studies have shown very promising effects for Cordiart® in use for blood vessel function, glycemic control and heart health.
In order to test novel substances regarding their effects on adipose tissue (fat storage cells), new ‘humanized’ in vitro models are needed. AdipoPhYt is currently developing a cutting edge new technology “AdipoGut”, combining all present techniques and knowledge into a high quality and predictive test system. The FlaMeS project will result in a marketable functional food ingredient “Cordiart®”, with proven beneficial effects on blood flow, glycemic control and heart health and a cutting edge new in vitro screening technology.
“We are very happy with the Eureka/Eurostars commission’s trust in our project, as this clearly shows that they recognize our serious efforts in developing cutting edge food ingredients and food development technology at BioActor and our partner AdipoPhYt. This grant will enable us to further enhance our scientific knowledge on the effects of polyphenols on the human body and validate our product Cordiart®, which may even revolutionize the health market in cardiovascular disease prevention,” says Hans van der Saag, CEO BioActor.
About BioActor
BioActor, based in Maastricht, Netherlands, is a product development company that has developed a range of proprietary bioactive ingredients for the nutrition & healthcare industry. The company focuses on the development of innovative activities that address active living and healthy aging. The goal is to provide the nutrition & healthcare industry with science-based innovations that confer a real health benefit to the consumer.
Feel free to contact us via info@bioactor.com for more information on the possibilities Cordiart® has to offer.
Further information can be found on: www.cordiart.com
