Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults.
Condition: Biological Availability
Study type: Interventional

Summary: 
      Mastiha is a natural product from the tree Pistacia lentiscus var. Chia (Anacardiaceae)
      growing exclusively in the Southern part of Chios Island. It is the natural resinous exudate
      produced after longitudinal incisions made at close intervals from the base of the trunk up
      to the thicker branches of the tree. U.S. Food and Drug Administration has classified Mastiha
      as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory,
      antimicrobial and antioxidant properties. In addition, the European Medicine Agency has
      recently recognized Mastiha as a natural medicine and classified it to the category of
      traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin
      inflammation and healing (EMA/HMPC/46758/2015).

      However, the bioavailability of its microconstituents in human biological samples is still
      undetermined. To this end, the current study aims to investigate the whether Mastiha's
      compounds are bioavailable in healthy adults. Twenty apparently healthy men, aged 20-40 years
      old, will be enrolled based on certain inclusion and exclusion criteria. The staff of the
      study will provide detailed information regarding the aims, the methods, anticipated benefits
      and potential hazards of the study and all patients will receive the Patient Information
      Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to
      participate in the protocol. Each patient agreeing to participate will sign an Informed
      Consent document and the staff will explain to patients that they are under no obligation to
      enter the trial and that they can withdraw at any time during the trial, without having to
      give a reason. A copy of the signed Informed Consent will be given to the participant.

      After enrollment, the volunteers will undergo a medical and dietary assessment and their
      health status will be evaluated through a complete blood count. Then, they will follow a
      low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables,
      legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and
      after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood samples
      will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha intake. Until
      timepoint 6h, they will be allowed to consume only water. Urine samples will also be
      collected on timepoints 0h, 4h, 8h and 24h.

      After collection, the phenolic and terpenoid content or metabolites of Mastiha will be
      identified in plasma samples applying LC-HRMS. Additionally, the metabolomic profile will be
      assessed in plasma samples with LC-HRMS and in urine samples with NMR-based metabolomics.
      Oxidative stress will be evaluated through the CuSO4 technique and oxidised LDL levels in
      serum samples, as well as F-2 isoprostanes in urine samples.
    


Intervention name(s): Mastiha
Intervention type(s): Other
Intervention description(s): The volunteers will follow a low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables, legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood samples will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha intake. Until timepoint 6h, will be allowed to consume only water. Urine samples will also be collected on timepoints 0h, 4h, 8h and 24h.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Natural Mastiha, Bioavailability