Naturalpha's Clinical Investigation Center in Nutrition Experiences Great Success Among Health & Nutrition Professionals and Volunteers
> A year that allowed to demonstrate the relevance of the offer and provided services
In 2010, Naturalpha conducted several clinical studies on behalf of French and international clients (ingredients suppliers, food supplements and functional food industries). These studies were fully conducted by Naturalpha from the protocol up to the delivery of the results and final clinical report to the client. The study duration varied from a few weeks to several months. These studies occurred at different stages of product development, such as bioavailability or tolerance studies, proof of concept or efficacy on health effects of ingredients or finished products (functional foods and food supplements) containing plant extracts, prebiotics, probiotics, vitamins, minerals, fatty acids.... Several health topics have been and will be addressed in the coming months within the CNCN such as weight management, cholesterol, glucose metabolism, immune modulation, gut health, constipation, menopause, vision... In addition, a major cohort-monitoring research project in cardiometabolic disorders will be also launched. These activities during the first year also highlighted the relevance of the partnership with the Hospital (a member of the GHICL) which allowed an access to the laboratories and very specific technologies such as the DEXA scan (for the evaluation of the fat mass), measurement of colonic transit time… These tools are especially useful to run clinical trials according to EFSA standards.
> Promising preliminary findings of the completed clinical studies and future trials
In the field of weight management, a study in weight management recently completed with around hundred volunteers confirmed a very good compliance mainly linked to the high quality of the clinical team. Despite several visits and intensive examinations such as DEXA scan, the dropout rate of volunteers remained very low. Also in others studies where the volunteers have to stay several hours in the center for a glucose tolerance test the readiness for participation and high compliance is confirmed. Studies such as to compare the bioavailability (proportion of the substance that reaches the bloodstream) of active ingredients in food supplements in liquid and dry dosage forms (tablets, capsules, syrup...) have also been conducted in the center. First results on the studies completed are very promising and will contribute largely to the development of future health products and ingredients.
Building on its success, Naturalpha has increased demands from companies to perform studies in its clinical investigation center with permanent launches of new studies for EFSA Health Claim dossiers in different fields (such as vision, blood pressure, satiety, menopause, constipation…).
> Satisfied volunteers involved in healthy food
The majority of participants in clinical trials in nutrition have through satisfaction questionnaires emphasized the quality of care within the center, the availability of the team and the transparency on the studies and products tested. Not only did volunteers contribute to advance science and develop tomorrow’s products in compliance with the strictest conditions they also particularly appreciated the opportunity to learn more about their eating habits. When launching its clinical center Naturalpha has indeed also promised to contribute in the education of volunteers towards a responsible eating behavior.
The full medical checkup performed on each volunteer before joining any study, the analysis of their eating habits combined with regular monitoring of their diet, make them more aware of the regional health issues, such as obesity and cardiometabolic disorders. This prevention aspect is part of the long term strategy led by Naturalpha within the regional Nutrition Health Longevity cluster. - Press Release – May 4, 2011 - Press Release -
Jean-François Jeanne, Clinical Study Director at the CNCN: «This first year of activity has shown the relevance of our clinical trials offer in nutrition coping with the EFSA regulation on Health Claim dossiers. Our access to the Hospital facilities allowed Naturalpha to fully manage the clinical trials in its investigation center (CNCN) complying with the strict timelines and high compliance of the volunteers. Our large volunteers database, the skills of our operational team: nutritionists, doctors, technicians ... have allowed us to complete three major studies and meet the expectations of our customers involved in nutrition and health. Other studies are ongoing and, new studies will be launched. This, together with the large increase of volunteers that subscribe at our database, confirms Naturalpha’s great enthusiasm for the second year of its center. »
Further information
About Naturalpha’s Clinical Nutrition Center (CNCN)
The CNCN is located within the Hospital Saint Vincent de Paul, a major hospital in the center of Lille. The team is composed of physicians, nurses, clinical technicians and has access to a wide expertise, equipments, services and facilities of the Hospital.
The CNCN is designed in order to fully meet the needs of a clinical study in nutrition with healthy volunteers in facilities at the forefront of technology and in accordance with the high standards of safety and hygiene. For more information on the CNCN: www.cncn.naturalpha.com
Clinical nutrition studies
The study, with a duration of several months is performed in humans to evaluate the characteristics, effects and safety of functional ingredients, food supplements and finished foods. The conditions for a clinical study are strictly defined and regulated by law. Finally, the study participation must be voluntary. Every clinical trial must be approved in advance and monitored by an ethics committee consisting of physicians, statisticians, lawyers, and representatives of civil society etc., to ensure that risks are as low as possible in relation to the expected and verified benefits.
About Naturalpha
Naturalpha, specialized in consulting, scientific and clinical research in Nutrition and Health, offers functional ingredients, food supplements and finished food manufacturers’ solutions to build a relevant research strategy. Naturalpha supports its industrial partners in building the proof of "health effect" of their innovative products at every stage of their development by proposing scientific and regulatory intelligence, consulting, health claim dossier audit, preclinical and clinical studies. Spin-off of the biotechnology company Genfit, Naturalpha is located in Lille with an office in Cambridge (Massachusetts, USA). Naturalpha employs 25 specialists (physicians, engineers, research scientists and dieticians) and is a member of the Nutrition Health Longevity Competitivity Cluster. www.naturalpha.com
Contacts :
NATURALPHA
Marleen VAN D’HUYNSLAGER
Phone: (+33) 3 20 95 95 08
MILESTONES – PR
Jacques-Olivier COSTA
Phone: (+33) 1 75 44 87 42
jocosta@milestones.fr