Incorporation of relevant pharmacological activity to food supplement beverage mix to establish functional food status. Clinical Research Division Biologic Nutrigenomic Health Research Corp. 688-2397 King George Hwy, BC V4A 7E9 www.biologicnr.com Research/Trial Director: Prof Franco Cavaleri BSc NB
The laboratory set out to create and test a proposed formulation for palatability, tolerability and pharmacological activity and provided clinical data for NEW monograph approval by Health Canada and NPN status for novel functional foods with drug –like qualities for the treatment of specific ailments. Formal documentation published from the ensuing clinical trial will be crafted from the data collected validating some of the structure and function health claims and safety.
Investigation of the metabolic pathways involved have been studied and reported on by this research firm since 1996. These current trials are designed to validate the theoretical proposition related to this investigative groundwork led by the Trial Director since that time.
Trial results demonstrated that the proposed formulations and the recommended carriers for the pharmacological agents were effective on all parameters – palatability, tolerability and pharmacological activity – demonstrating therapeutic as well as commercial viability for THREE of the FOUR biological agents tested. Pharmacology includes:
-measuring tangible biological markers related thermogenic activation;
- appetite suppression through postprandial cholecystokinin (CCK) induction / secretion (measured after the base carrier ingestion and after the active agent was added to the standardized carrier);
-WOMAC evaluation of joint pain by subjects
-energy evaluation over the ingestion period
The substance that failed the palatability test irrefutably passed the efficacy test but we could not proceed without more costly work which may involve a microencapsulation technique to nano-encapsulate the nutraceutical in order to guard it from sensory reception.
These positive findings on health and disease have set the stage for the development of a larger trial which we expect to engage in with a subject group made up of individuals with broader age and health status range.
Trial and Report prepared by: Prof Franco Cavaleri BSc NB