Human clinical studies
Clinical trials for testing safety and functionality of food products
The BioCC LLC offers a possibility for enterprises to get up-to-date, science-based and truthful information and consultations for safety, tolerability and health –promoting effect of foodstuffs.
The service includes three-levels testing of foodstuffs, from which the most suitable can be chosen.
I: Safety testing of the (functional) food product includes two stages
- Analysis of the food product recipe by the nutritionists and scientists of the BioCC
The analysis gives recommendations for the manufacturer to change (if necessary) the product recipe in order to eliminate undesirable components or to improve the product recipe with a health-promoting components
- Human intervention trials with healthy volunteers to evaluate the safety of the food product.
The effect of postprandial or for 3-4 weeks administration of the food product, a number of routine markers in clinical practice (blood serum glucose; cholesterol and fractions; kidney, liver and inflammation markers) from blood and urine samples will be measured to evaluate the safety of the product.
II: Tolerability and safety testing of the (functional) food product on healthy volunteers during a human intervention trial:
In addition to routine clinical markers, measurement of specific markers from blood/urine, and a self-reporting questionnaire will be used to evaluate the safety and the tolerability of the food product.
III: Efficacy and safety (and tolerability) testing of the (functional) food product
During a clinical testing of the product on healthy volunteers for 4-8 weeks,
- measurement of a large number of routine clinical markers from blood / urine samples (incl. markers of kidney, liver inflammation),
- measurement of basic and new indicative markers from blood / urine / faecal, markers describing the health-promoting effect of the product on human body physiology
- a self-reporting questionnaire will be used
The study design, and markers measured, will be selected depending on the specific features of the particular product.
Testing of food products is carried out in the Laboratory for Clinical and Physiological Research of the BioCC LLC (Riia 181a, Tartu, Estonia). We work in close collaboration with Tartu University Hospital.