Kliinilised uuringud

Kliinilised uuringud

Clinical trials, also known as clinical studies, test potential treatments (food supplement, value added-foods, etc.) in human volunteers to see whether they should be approved for wider use in the general population.

BioCC LLC owns the unique Laboratory for Clinical and Physiological Research in Baltic for conducting, in accordance with EU and international legislation and scientific practice, in vivo safety, tolerability and efficacy trials with food, dietary supplements and feed.

The Laboratory for Clinical and Physiological Research conforms the requirements of EVS-EN ISO/IEC 17025:2006 as testing laboratory.

The laboratory is the part of the ECRIN Network which is a not-for-profit organisation that supports multinational clinical trials.

Our aim is to focus on the provision of clinical research services to all manufacturers who are looking for scientific evidence of the effects of their products (incl. possible health-promoting effects). The manufacturers can be as follows: food manufacturers; food supplement manufacturers; animal feed manufacturers; feed additives manufacturers; distributors of animal feed and feed additives.
The core team has the medical backround, and its members are the professionals nutritionists, biochemists, clinicians, medical microbiologists, statisticians, etc. We have long term cooperation with the Tartu University Hospital clinics and laboratories.

The team of the BioCC is capable of providing an integrated approach, starting with consultations related to product composition and its suitability for testing with the aim to improve its properties, with clinical and animal physiology tests. BioCC LLC has the competence of conducting clinical trials from the idea to the implementation and proof, it includes the protocol and application for ethic commitee, competent personal and logistics, analysis of results and documaentations of tests results and issuance of the certificate. Our strenghts lies in our expertise in generation / compilation of relevant / essential documents for healt claims applications from EFSA.

BioCC LLC has conducted several human intervention trials in cooperation with the Medical Faculty of the University of Tartu testing the effect of (functional) food products and food supplements on various health indices of human body.

All our conducted trials have the approval of Research Ethics Committee of the University of Tartu and are registered at the ISRCTN regitry database. The list of our conducted trials are as follows:
ISRCTN38739209. Effect of probiotic cheese on blood indices and intestinal microflora of healthy volunteers.
ISRCTN45791894. Effect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers.

ISRCTN68198472. Effects of probiotic cheese on blood indices and intestinal microflora of healthy volunteers.

ISRCTN15061552. Effect of probiotic cheese on blood indices and intestinal microflora of healthy volunteers and elderly individuals.

lSRCIN79645828. Effects of probiotic yoghurt comprising L.plantarum strains TENSIA® or INDUCIA® on blood indices and intestinal microflora of healthy volunteers: a randomised controlled crossover trial.

ISRCTN42449576. Effect of different doses of L.plantarum TENSIA® comprising probiotic cheese on clinical parameters of volunteers.

lSRCIN88420027. Effects of probiotic yoghurt comprising L.plantarum strain INDUCIA® on blood indices and intestinal microflora of healthy volunteers: a randomised controlled cross over trial.

ISRCTN29040130. Effect of the probiotic Südamejuust (heart friendly cheese) comprising L.plantarum TENSIA® DSM 21380 on subjects with high-normal blood pressure: a randomized blinded controlled parallel three arm study.

ISRCTN24502121. Effect of food supplement containing the probiotic strain of L.plantarum TENSIA® DSM 21380 on blood indices and intestinal microflora of healthy volunteers: a randomized placebo-controlled parallel trial.

lSRCIN26344255. Effect of probiotic yoghurt comprising L.plantarum strain INDUCIA® on healthy volunteers: a randomized blinded controlled parallel designed two armed study.

ISRCTN29105501. Effect of the probiotic Südamejuust (heart friendly cheese) comprising L.plantarum TENSIA® 

DSM 21380 on subjects with high-normal blood pressure: a randomized blinded controlled parallel designed two armed study.

ISRCTN51441547. Efficacy of whey-based dairy products in the case of the men with moderate urination problems.

ISRCTN18123188. Safety and tolerance testing of the synbiotic product of L. plantarum INDUCIA® and xylitol in adult and elderly persons.

272/T-15 Effect of a food supplement containing L. plantarum TENSIA® DSM21380 on the subjects with high-normal blood pressure up to grade-1 hypertension: a randomized blinded controlled parallel designed two armed study.