In Vivo Acute Toxicity and Immunomodulation Assessment of a Novel Nutraceutical in Mice.

Achieving and maintaining a well-balanced immune system has righteously become an insightful task for the general population and an even more fundamental goal for those affected by immune-related diseases. Since our immune functions are indispensable in defending the body against pathogens, diseases and other external attacks, while playing a vital role in maintaining health and modulating the immune response, we require an on-point grasp of their shortcoming as a foundation for the development of functional foods and novel nutraceuticals. Seeing that immunoceuticals are considered effective in improving immune functions and reducing the incidence of immunological disorders, the main focus of this study was to assess the immunomodulatory properties and possible acute toxicity of a novel nutraceutical with active substances of natural origin on C57BL/6 mice for 21 days. We evaluated the potential hazards (microbial contamination and heavy metals) of the novel nutraceutical and addressed the acute toxicity according to OECD guidelines of a 2000 mg/kg dose on mice for 21 days. The immunomodulatory effect was assessed at three concentrations (50 mg/kg, 100 mg/kg and 200 mg/kg) by determining body and organ indexes through a leukocyte analysis; flow cytometry immunophenotyping of lymphocytes populations and their subpopulations (T lymphocytes (LyCD3+), cytotoxic suppressor T lymphocytes (CD3+CD8+), helper T lymphocytes (CD3+CD4+), B lymphocytes (CD3-CD19+) and NK cells (CD3-NK1.1.+); and the expression of the CD69 activation marker. The results obtained for the novel nutraceutical referred to as ImunoBoost indicated no acute toxicity, an increased number of lymphocytes and the stimulation of lymphocyte activation and proliferation, demonstrating its immunomodulatory effect. The safe human consumption dose was established at 30 mg/day.

Evaluation of the Putative Duplicity Effect of Novel Nutraceuticals Using Physico-Chemical and Biological In Vitro Models.

Nutraceuticals are experiencing a high-rise use nowadays, which is incomparable to a few years ago, due to a shift in consumers' peculiarity tendencies regarding the selection of alternatives to Western medicine, potential immunity boosters, or gut-health promoters. Nutraceuticals' compositions and actual effects should be proportional to their sought-after status, as they are perceived to be the middle ground between pharma rigor and naturally occurring actives. Therefore, the health benefits via nutrition, safe use, and reduction of potential harm should be the main focus for manufacturers. In this light, this study assess the nutritional profile (proteins, fats, fibers, caloric value, minerals) of a novel formulated nutraceutical, its physico-chemical properties, FTIR spectra, antioxidant activity, anthocyanins content, and potential hazards (heavy metals and microbiological contaminants), as well as its cytotoxicity, adherence, and invasion of bacteria on HT-29 cells, as well as its evaluation of beneficial effect, potential prebiotic value, and duplicity effect on gut microbiota in correlation with Regulation (EC) No 1924/2006. The results obtained indicate the growth stimulation of Lb. rhamnosus and the inhibitory effects of E.coli, Ent. Faecalis and Lc. lactis. The interaction between active compounds suggested a modulator effect of the intestinal microbiota by reducing the number of bacteria that adhere to epithelial cells or by inhibiting their growth.

The Biological Effects of Novel Nutraceuticals with Curcuminoids and Other Plant-Derived Immunomodulators and Pre-Probiotics.

An effective and well-balanced immune system is pivotal for maintaining health. Diet and nutrition can affect the functioning of numerous immune parameters, with direct repercussions on homeostasis. Since our immune functions are indispensable in defending the body against pathogens and thus play a vital role in maintaining health, modulating immune response may well serve as the basis for the development of plant-based functional foods and novel nutraceuticals. This concept is currently utilized in attempts to prevent or mitigate inflammatory reactions via the development of targeted food products or active ingredients since an extended number of phytoconstituents (such as curcuminoids) are associated with beneficial effects on immunity. Immunomodulatory plant-based dietary supplements are considered effective in improving immune functions and reducing the incidence of immunological disorders or imbalances. Therefore, the main focus of this study was to evidence the beneficial biological effects such as antioxidant and antimicrobial, as well as nutritional status, biocompatibility and cell proliferation capacity and immunomodulation of two novel nutraceuticals. The first nutraceutic was based on curcuminoids and other actives from Trigonella foenum- graecum (seeds), Chelidonium majus L. (aerial parts), Taraxacum officinale L. (roots), vitamins (C, D3, A, E) and minerals (zinc) whereas the second one was made of probiotics such as Lactobacillus acidophilus and Bifidobacterium animalis subsp. Lactis combined with actives from Helianthus tuberosus (tubers) and Psyllium/Plantago ovata (husk) as herbal prebiotics.

Spectroscopic and Spectrometric Methods Used for the Screening of Certain Herbal Food Supplements Suspected of Adulteration.

Purpose: This study was carried out in order to find a reliable method for the fast detection of adulterated herbal food supplements with sexual enhancement claims. As some herbal products are advertised as "all natural", their "efficiency" is often increased by addition of active pharmaceutical ingredients such as PDE-5 inhibitors, which can be a real health threat for the consumer. Methodes: Adulterants, potentially present in 50 herbal food supplements with sexual improvement claims, were detected using 2 spectroscopic methods - Raman and Fourier Transform Infrared - known for reliability, reproductibility, and an easy sample preparation. GC-MS technique was used to confirm the potential adulterants spectra. Results: About 22% (11 out of 50 samples) of herbal food supplements with sexual enhancement claims analyzed by spectroscopic and spectrometric methods proved to be "enriched" with active pharmaceutical compounds such as: sildenafil and two of its analogues, tadalafil and phenolphthalein. The occurence of phenolphthalein could be the reason for the non-relevant results obtained by FTIR method in some samples. 91% of the adulterated herbal food supplements were originating from China. Conclusion: The results of this screening highlighted the necessity for an accurate analysis of all alleged herbal aphrodisiacs on the Romanian market. This is a first such a screening analysis carried out on herbal food supplements with sexual enhancement claims.