Clinical study services for food products: interventions for health claims and novel foods
Clinical studies with food products are conducted to support health claim dossiers or novel food applications, following the latest requirements of the European Food Safety Authority (EFSA). Medfiles conducts intervention studies with finished food products and food ingredients, as well as proof-of-concept or pilot studies that support R&D efforts for new ingredients. All studies are conducted in accordance with applicable Good Clinical Practice (GCP) requirements.
In addition to our comprehensive regulatory services, Medfiles offers various clinical study services for food products with 10+ years of experience. Our support covers the full study lifecycle – from study planning, site selection and regulatory submissions to monitoring, project management and final reporting. With experienced project managers and clinical research associates, we ensure smooth coordination, GCP compliance and scientifically robust, well-documented studies that meet the expectations of authorities.
We also offer clinical trials for medicines and clinical investigations and performance studies for medical devices and IVDs.
Food interventions for health claims
Medfiles has extensive experience in planning clinical studies. We oversee to that the efficacy documentation meets the expectations of the authorities when the objective is to achieve a health claim approval in the EU. The process starts with our regulatory expert team deciding the wording of the health claim, which is often done after a gap analysis of the existing documentation. After this, our clinical team works in close collaboration with the client and regulatory experts define suitable outcome variables and the appropriate study design to meet the ultimate goal, the approval of the health claim.
Food interventions for novel foods and GRAS (Generally Recognized As Safe) ingredients
For novel foods and new food ingredients, the EU market approval, and GRAS approval in USA, requires human safety data to substantiate the dossier. Medfiles conducts clinical trials on food ingredients to demonstrate the safety of food products in the short and long-term.
Particulars in dietary interventions
Once a diet is intervened, it is of utmost importance to collect data on the use of the test food product, but also on any other changes in the habitual diet. Medfiles with its qualified nutrition experts can plan and perform dietary monitoring, including the appropriate records and methodology, and thereafter make the required nutrient intake calculations. See also:
EXPERIENCE – Clinical study services for food products
Medfiles has a proven track record of multiple dietary interventions with various types of food in various health areas. Our permanent professional site partners can perform even the most demanding nutrition interventions.
Foods tested
- Cereals
- Snacks
- Drinks
- Comprehensive diet modifications
Ingredients tested
- Fibers
- Lipid ingredients
- Bioactive peptides
- Probiotics
- Polyphenols
Health areas
- Safety
- Cardiovascular risk factors
- Glucose metabolism
- Cognitive functions
- Skin health
clinical team leader
Essi Sarkkinen, Director, Clinical Research and Medical Device
Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit. In March 2025, she was appointed Director of Clinical Research and Medical Device.
Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. After her academic career, she has worked for over 15 years managing and leading contract research in the field of food and nutrition. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food product, like health claims and novel foods.
Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.
