Periodic Reporting for period 1 - MAST4HEALTH (Mastiha treatment for healthy obese with NAFLD diagnosis (MAST4HEALTH).)
Reporting period: 2016-03-01 to 2018-02-28
Nonalcoholic fatty liver disease and steatohepatitis (NAFLD/NASH) is one of the most common liver disorders and a major public health problem in Europe and North America and one of the most common complications of obesity and diabetes mellitus in Western populations affecting approximately 50% of diabetics and 76% of obese patients. MAST4HEALTH consists a multidisciplinary approach to assess a non pharmacological intervention for managing NAFLD/NASH. Because of limitations in current NAFLD treatment therapies, many new efforts focus on exploring non-pharmacologic means for managing the disease and in particular through dietary substances or bioactive phytochemicals in fruits, vegetables, and plants or their products. MAST4HEALTH aims at exploring the effect of Mastiha, a natural product of Greece which was recently shown to possess antioxidant/anti- inflammatory and lipid lowering properties. We designed a multicenter randomized double blind placebo controlled (parallel arm) clinical trial to test the effectiveness of Mastiha supplement as new non-pharmacologic strategy for NAFLD/NASH treatment. MAST4HEALTH will explore gene-diet interactions, more specifically the potential personalized activity of the Mastiha, and correlate genetic and epigenetic markers with metabolomic and intestinal microbiota profiles pre- and post- intervention. The effectiveness of the proposed intervention will be evaluated via clinical and laboratory markers of the disease. To this end, MAST4HEALTH will train a number of researchers and PhD students in multidisciplinary approaches of this survey. MAST4HEALTH is expected to build and enhance cooperation among partners meanwhile strengthening the interaction between our academic and non-academic sectors
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
"During the first two years of the project, all NAFLD/NASH patients were succesfully recruited. The clinical trial is ongoing in the four clinical trial sites of the project. All baseline biological samples were transferred to the central laboratories and all protocols were designed and optimized. A MAST4HEALTH site (http://www.mast4health.eu/en/) is created and all actions related to the project are presented there. Secondments are taking place with great success and a training process is ongoing, with a career development portal (http://mast4health-career.com/) evaluating secondments through the completion of questionnaires at the beginning and the end of each secondment (from both secondees and supervisors). Three meetings of the group (kick-off meeting, RCT meeting, 1st annual meeting) took place the first two years with two courses being included in them ('Practical issues in NAFLD/NASH diagnosis and management’ and “New high-throughput DNA sequencing technologies for clinical diagnosis"")."
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
MAST4HEALTH includes state of the art technologies, analytical techniques, facilities and instrumentation. LiverMultiScan is a non-invasive medical imaging software tool which, combined with MRI, quantifies inflammation and fibrosis by measuring iron and fat fraction and calculating the Liver Inflammation and Fibrosis (LIF) score. It is ideal for screening patients to enter trials as it takes 20 min for whole liver scan. Our central labs use cutting-edge methodologies for the analyses and integration of all biological samples and data derived from the clinical trial. The expected impact of our project is multidimensional. Not only the exploitation of a non-pharmacological treatment, but also the training of researchers on new therapeutic approaches will contribute to more efficient management of NAFLD/NASH, increase clinical efficacy and reduce costs of treatment. On the other hand, close collaboration between partners for the training of researchers in multidisciplinary techniques, contributes to a new approach where academic and non-academic sector work together for the education of Europe future scientists.