Working Modules & Methods

In order to successfully complete the objectives of HYPER-MASTIC research project, all the planned actions have been organized into 5 Working Modules, each containing sub-working modules, lasting a total of 30 months. All modules are successive and complementary with specific sub-objectives.

The five Working Modules are as following:

1) Receiving and Quality Control of raw material (resin) and Chios Mastic products

HYPER-MASTIC’s first step is the receipt of Chios Mastic (the raw material will be supplied by Chios Gum Mastic Growers Association L.L.C.) and the development of certified, detailed quality control methodologies of the resin and its byproducts.

The development of detailed quality control methods that are in accordance with the principles of the European Pharmacopoeia, will be carried out by the Department of Pharmacy, Sector of Pharmacognosy and Chemistry of Natural Products, National and Kapodistrian University of Athens (UOA), along with IASIS PHARMA pharmaceutical company, using GC-MS, LC-HRMS, HPT and HPLC-DAD techniques. The best out of these methods will be validated and promoted for certification and industrial production.

2) Extraction, isolation and identification of Chios Mastic active ingredients

HYPER-MASTIC research project has three essential sides: extraction-isolation-identification. More specifically, the Sector of Pharmacognosy and Chemistry of Natural Products (UOA), in collaboration with Chios Gum Mastic Growers Association, will proceed to the application of "green" extraction techniques (ACE, SFE and CPE) and separation (CPC and SFC-UV), aiming to isolate all active ingredients and subsequently identifying them by LC-HRMS and NMR techniques.

3) Biological Evaluation of Chios Mastic in cellular and in vivo experimental models

Both the extracts and the isolated ingredients that will result from the second working module, will be evaluated for their potential cardioprotective / antihypertensive action and safety.

More specifically, the extracts will be evaluated at a genetic and cellular level, to study a series of parameters (antioxidant potential, protection against oxidative stress, activation of cytoprotective mechanisms).

This evaluation will be carried out by the Department of Biology, Sector of Cellular Biology and Biophysics, UOA. The 8 most bio-active extracts will also be studied in vivo in a rat experimental model, as well as with genomic and transcriptional approaches to further understand their action at a molecular level – study that will be carried out by the Department of Nutrition and Dietetics, Harokopio University.

Last, but not least, development and application of metabolic approaches using mass spectrometry will take place, for the detection of the components of Chios mastic in cellular systems and / or biological fluids. These approaches will be performed by the Department of Pharmacy, Sector of Pharmacognosy and Chemistry of Natural Products (UOA).

4) Clinical study in hypertensive volunteers with Chios mastic product (in tablet form)

Following the above results’ evaluation, production of a specific Chios mastic formulation will take place, which will be used to conduct a clinical study in hypertensive volunteers.

This new pharmaceutical product -with Chios mastic as its active ingredient- will be produced by IASIS PHARMA. IASIS PHARMA, in cooperation with the Therapeutical Clinic of Medical School, UOA, will conduct a double-blind, randomized study, which will include 3 groups (35 people per group) of hypertensive patients. Volunteer selection and monitoring protocols will be followed in accordance with international regulations, while the number and dosage regimen will be calculated based on pilot preliminary studies carried out by the research network.

Blood and urine samples will be taken from the volunteers (420 blood samples) at specific periods (0, 1, 2 and 3 months). Documented examinations will be performed in all patients, to evaluate multiple parameters of the function and structure of the cardiovascular system, before and after the administration of the Chios mastic pharmaceutical product.

5) Clinical study’s biological samples analysis

The final stage of HYPER-MASTIC scientific study includes the volunteers’ biological samples (blood) analysis. More specifically, a bioavailability study will be conducted, regarding the components of Chios mastic (210 per biological fluid, multiplied by 4 points), as well as metabolic studies, aiming to highlight bio-indicators - molecules. In this task, Department of Pharmacy, Sector of Pharmacognosy and Chemistry of Natural Products (UOA) will be cooperating with IASIS PHARMA.

Furthermore, the pharmaceutical product in use will be tested regarding the activation of cell-protective mechanisms (such as antioxidant activity, proteasome activation) both at molecular and cellular level. That will be examined by the Department of Biology, Sector of Cellular Biology and Biophysics, UOA.

Finally, the Department of Nutrition and Dietetics, Harokopio University will conduct extensive genomic and transcriptomic analyzes, to record the molecular basis of Chios mastic products’ action mechanism.

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