Clinical studies
Clinical studies to test food safety and functionality
We offer clinical trials to test the safety, tolerability and new functional properties of food and dietary supplements. After investigations, we can help you complete the health claims documentation.
Science-based clinical trials are necessary to investigate, for example, the effects of a new probiotic microbe or product on human health. In cooperation with the University of Tartu, we have conducted several impact studies to test the impact of various (functional) foods and nutritional supplements on human health. We conduct clinical studies with different test schemes (open label, double-blind studies, placebo-controlled double-blind studies) to describe the functionality of our own products.
Therefore, we also offer other companies modern and science-based advice on the safety, tolerability and health-promoting effects of foods. The service includes three levels of testing from which you can choose the appropriate one:
​I: Tolerability and safety testing of a functional food product in healthy volunteers (impact study):
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In order to evaluate the effect of the food product after eating or after 2-4 weeks of administration, changes in various health indicators are analyzed, including the most commonly determined analyzes in medical practice (e.g. fasting blood glucose level, serum cholesterol and its fractions, kidney and liver indicators and inflammation indicators, etc.).
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In addition to basic clinical parameters, specific and experimental parameters are measured from blood/urine and a survey is used to assess the safety and tolerability of the food product.
​II: Evaluation of the health effects of functional food products:
Based on the purpose of the study, the data collected from healthy volunteers included in the sample will be analyzed (results of biological sample analyzes and answers to questionnaires) in order to clarify the mechanisms of action and positive health effects of the researched product.
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From biological samples, daily used and new indicators are measured from blood, urine and feces samples in standard practice;
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Different questionnaires are used.
Our clinical research laboratory:
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Internationally registered and transparent studies;
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A multidisciplinary, experienced and professionally competent team. There is long-term experience in conducting clinical trials of food products and nutritional supplements, including planning and conducting the trial and analyzing the results;
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We have the knowledge, experience, mental - and infrastructure for quantitative and qualitative analyzes of biological material of human origin;
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Our laboratory is licensed to handle infectious material;
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We have the know-how to conduct three different levels of food studies: two-stage safety and tolerability studies of a food product or dietary supplement and health benefit (impact) studies;
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Clinical application studies to clarify (prove) the healthiness/functionality of products from 2 aspects: safety and mechanisms of action (e.g. lipid metabolism, inflammation, immune response, liver health markers, oxidative stress, vascular function, metabolomics, etc.).
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The structure of the study and the measured indicators are chosen (based on) the specific characteristics of a particular product. Our long-term cooperation partner is SA Tartu University Clinic together with SA TÜK Ühendlabor.