OBJECTIVE

Bone metabolism and microbiome
It is now proven that the gut microbiome regulates bone metabolism through the absorption of calcium and other minerals. Also, studies show that the regulation of the gut and its microbiome can affect bone density and endurance in a variety of animal models and humans. At the same time, there has been increased interest in the interactions of polyphenols – intestinal microbiome and especially flavonoids of the catechins. In fact, it has been observed that through the microbiome they are converted into bioactive compounds, while the polyphenols themselves can modify the composition of the intestinal microbiome. At the same time, concomitant indicators of effectiveness and tolerance will be explored. The selection of herbal ingredients for the dietary supplement will be done through in vitro and in silico experiments taking into account their effect on the regulation pathways of osteoclasts and osteoblasts. The evaluation of the effectiveness and tolerability of the new supplement will be carried out through randomized clinical intervention. The proposed project results from the collaboration of three highly complementary research bodies and two companies. The new dietary supplement will focus on the rich potential of the intestinal microbiome and will enable the partnership to further develop targeted supplements with innovative approaches.

The object of the proposed work is the design and development of an innovative dietary supplement for osteoporosis focusing on the mechanisms of the microbiome, as well as the use of accompanying biomarkers for the effectiveness – tolerance of this supplement.


Sub-objectives for the project are:
(a) the design of a new dietary supplement. The selection of natural ingredients will be carried out through in vitro and in silico experiments taking into account their effect on the regulation pathways of osteoclasts and osteoblasts.
(b) evaluation of efficacy and tolerability through clinical intervention of (i) calcium and vitamin D supplementation, (ii) calcium, vitamin D and prebiotic supplementation, and (iii) supplementation as in (ii) but with the addition of specific polyphenols , always compared to placebo in osteopenic postmenopausal women
(c) the discovery and validation of new biomarkers of efficacy and tolerability in osteopenic postmenopausal women
(d) the development of guidelines for the use of prebiotics and puphenols in osteoporosis supplements